Posted: 15 June
The role
Quality Operations Manager
Summary of Role:
This operational quality leadership position drives quality excellence across the business unit. The role encompasses comprehensive ownership of quality processes, documentation standards, and regulatory compliance while serving as the primary quality liaison for key customer relationships and critical quality initiatives.
Key Responsibilities
Lead the development and execution of quality operations, overseeing all batch manufacturing record generation and review; responsible for all production‑related quality assurance.
Partner with peer Quality Managers and the Quality Systems Manager to drive QA optimization strategies and generate company‑wide continuous improvement initiatives.
Establish cross‑functional quality training frameworks and capability development programs across all sites to ensure operational resilience and scalability.
Own the comprehensive governance of quality documentation systems, driving standardization, updates, and maintenance of all quality‑related forms and records.
Authorize and oversee deviation management and investigation protocols, ensuring swift resolution of process and product quality issues while maintaining customer satisfaction.
Ensure unwavering adherence to GMP standards and customer quality agreements, positioning the organization as a trusted quality partner.
Provide direction and leadership to the quality operations team (~10 direct reports), establishing performance frameworks and operational excellence standards.
Implement performance management systems that drive accountability and continuous improvement in batch completion metrics and quality indicators.
Champion a culture of quality excellence through regular coaching, mentoring, and professional development initiatives.
Execute systematic GEMBA leadership walks to assess operational standards, drive housekeeping excellence, and ensure comprehensive GMP compliance across all operations.
Oversee product inspection protocols and quality assessment frameworks, ensuring adherence to specification requirements and proactive issue resolution.
Direct quality operations across incoming goods receipt and related supply‑chain touchpoints.
Lead high‑level customer engagement initiatives, representing the organization in quality discussions and driving customer satisfaction through proactive quality partnership.
Serve as a leader for customer audit processes, ensuring successful outcomes and continuous relationship strengthening.
Champion process improvement initiatives and operational innovation projects, including transfer of new product introduction initiatives.
Establish and maintain deep technical expertise in packaging and quality processes, serving as the go‑to authority for customer and regulatory audit support.
Drive project leadership and cross‑functional collaboration to meet evolving business requirements and organizational objectives.
Essential Qualifications
Minimum 10 years’ experience in quality for a pharmaceutical company operating to EU GMP standards.
2–5 years’ experience in a leadership or team management role.
Broad and deep understanding of EudraLex Vol 4, its key chapters and annexes.
Understanding of serialisation requirements.
Flexible and willing attitude.
Strong communication skills to interact with internal and external customers at a senior level.
Team player with open communication style, ability to direct and train others, and deliver clear instructions to internal staff, customers, and suppliers.
Design and develop new equipment to improve line effectiveness.
Ability to influence and collaborate at all levels to achieve company targets.
Ability to represent the company in a professional and highly competent manner.
Ability to multitask and prioritise activities.
Ability to work independently as well as part of a team.
Excellent problem‑solving skills.
Dependable, reliable, and robust personal integrity.
Desirable Qualifications
Experience in a quality operations department, with responsibility for batch release supporting a Qualified Person function.
Experience in hosting regulatory inspections.
Detailed understanding of both primary and secondary packaging processes.
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Manager, Finished Goods Supply Planning (Remote Ireland)
Summary: The Manager, Finished Goods Supply Planning is responsible for setting supply plans in all warehouses in the EMEA region and ensuring stock availability. The position drives material availability actions within Beckman Coulter Diagnostics.
Key Responsibilities
Directly manage up to 8 associates throughout the EMEA region, as well as North America.
Identify opportunities and implement plans to improve on‑time delivery (OTD) and inventory.
Work with EMEA L&D to improve freight and material handling costs.
Lead large, cross‑functional groups on improvement initiatives.
Work with demand planning to create and adjust inventory plans throughout the region.
Report on group progress against KPIs which include employee engagement, OTD, inventory, and product availability.
Use the Danaher Business System to drive innovation and change.
Essential Requirements
Honours Bachelor’s Degree (Level 8) ideally within Supply Chain with a minimum of 6 years of experience or Master’s degree with 4 years of experience.
2 years of experience in direct management of multiple associates.
Experience leading associates in multiple geographies, representing multiple cultures.
Experience leading cross‑functional groups to attain common improvement goals.
Excellent written and verbal communication skills.
Ability to work in a methodical and accurate manner.
Additional Preferred Experience
Fluency in a second language.
APICS certification.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
- Ability to travel internationally or domestically 10% of the year.
- Although remote, must be able to travel to the Clare site 2 to 4 times per month.
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
QA Specialist – Audit
Summary of Role:
The role is to implement and execute tasks relating to GMP auditing and supplier qualification in the PCI sites in Ireland.
Key Responsibilities
Provide support during the preparation of client audits and regulatory inspections.
Support all aspects of the site Supplier Management Programme, including supplier audits, risk assessments, preparation of QTA's and supplier qualification.
Coordinate back‑room support activities for all major client audits and regulatory inspections.
Track all audit responses and action items to ensure they are completed within agreed timeframes.
Maintain, update and track the internal and supplier audit schedules including audit completion and response receipt.
Raise deviations, corrective action requests, and non‑conformance reports as required in a timely manner and ensure that issues are communicated to the audit manager/designee.
Ensure activities are in compliance with the requirements of cGMP.
Generate SOP/Forms/JA's/WI's on MasterControl.
Interact and communicate daily with staff and support departments.
Undertake ad‑hoc projects as required to meet department and business needs.
Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Essential Qualifications
Third‑level degree in Chemistry, Biology, Pharmacy, Engineering, or a related field.
Minimum of 3 years in a similar role / working in Quality Assurance, Quality Systems, Compliance.
Good working knowledge of cGMP and associated regulations (Eudralex Volume 4; ISO 13485).
Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
Ability to manage multiple tasks and set priorities.
Good interpersonal skills.
Willingness and ability to travel within Europe.
Strong analytical, communication, and reporting skills.
Proficiency in Microsoft Office and familiarity with quality systems (e.g., MasterControl).
Good written communication skills.
Desirable Qualifications
Supplier management and auditing experience.
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Validation Specialist (Permanent)
Summary of Role:
The role of the Validation Specialist is to implement and execute tasks relating to Process, Facility and Equipment Development at PCI Pharma Services sites.
Key Responsibilities
Ensure safe work practices are being followed at all times; report any near‑misses immediately to the EHS Department.
Ensure all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients and regulatory requirements (HPRA/FDA).
Comply with Site Validation Master Plan.
Generate validation protocols for new and existing computer systems, facilities, equipment and processes and review/approve all reports; also generate and maintain documentation for cleaning validation performed at PCI sites in Ireland.
Execute validation activities with minimal supervision in conjunction with Technical, Production and Engineering functions.
Perform sampling in support of validation studies, including AQL and cleaning validation.
Manage tooling validations and associated documentation.
Support complaint investigations, deviation investigations and change controls as required.
Identify and support opportunities for improving processes and/or procedures.
Perform periodic reviews and revalidations on a scheduled basis.
Work with Validation team to ensure a robust and compliant validation system is in place.
Carry out various other additional tasks as required from time to time in accordance with the overall goal of the company.
Essential Qualifications
Degree in Quality or Validation, or equivalent experience.
Minimum 2 years’ experience working in Manufacturing or Quality.
Demonstrate interest in Validation.
Ability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
Ability to manage multiple tasks and set priorities.
Problem‑solving and troubleshooting skills.
Self‑motivated with a results‑driven approach.
Flexibility to work across different shifts on request in line with business needs.
Proficient in Microsoft Office products.
Experience in a GMP or regulated environment.
Desirable Qualifications
Experience in Lean Manufacturing and continuous improvement tools.
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Customer Quality Lead (CPL)
Primary Responsibilities
Assist with performing record reviews of completed orders and orders in process to ensure compliance with cGMP’s and customer requirements.
Assist as company liaison with customers concerning quality batch documentation.
Help identify, communicate, track and resolve document‑related issues with other departments and customers.
Attend conference calls and customer meetings; provide complaint and quality‑related information.
Assist with generating and presenting quality‑related metrics and key performance indicators for team performance.
Assist with the investigation of quality deviations and drafting of investigation reports associated with such deviations.
Disposition of events and non‑conformances.
Assist with addressing and documenting quality events with production and quality teams.
Assist with training, developing, and mentoring new QA technicians.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position.
Perform other duties as assigned by Manager/Supervisor.
Develop, update, and implement procedural changes throughout QA operations.
Standardize documentation to ensure PCI’s standard for quality is achieved throughout our customer base.
Coach, train, mentor and develop PCI employees to ensure quality standards are met and maintained.
Assist with in‑process/finished goods inspections, annual retain inspections, customer complaint samples or rework as needed.
Compile, update and analyse customer/internal data and metrics to identify potential trends and opportunities.
Maintain positive external and internal customer relationships through face‑to‑face, email and voice communication.
Assist with supplier investigations as needed.
Assess and provide detailed reports/summaries on the impact of process changes to PCI management.
Requirements
Bachelor’s degree in Pharmacy, Microbiology, Chemistry, Biology or related fields.
Minimum 1 year of pharmaceutical industry experience.
Ability to work with minimal supervision.
Proficiency with MS Office Suite programs.
Excellent attention to detail.
Superior communication skills.
Skill at driving and providing training to other staff members.
Strong analytical and problem‑solving skills.
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Global Commercial Assembly & Packaging Engineer
Essential Duties and Responsibilities
Lead engineering standards and best practices for assembly & packaging equipment specification, build management, and commissioning in all PCI sites.
Strategic focus for equipment‑specific technology development appropriate to the PCI CDMO working environment.
Work with Business Development and new clients to define equipment and process requirements; provide subject‑matter expertise and hands‑on work during equipment design, FAT, SAT and validation.
Maintain quarterly business reviews for responsible OEMs and drive KPIs to best in class.
Develop a skill set gap analysis for engineers and technicians in the equipment and troubleshoot high‑speed automation assembly and packaging equipment.
Develop an ongoing technical training academy to enhance equipment knowledge for our sites, support troubleshooting and reduce mean time to recovery on equipment issues.
Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules, and regulations as applicable to assigned tasks.
Position may require overtime and/or weekend work.
Qualifications
Education: Bachelor’s or Master’s degree in an Engineering discipline (Mechanical, Chemical, Electrical, Industrial, or IT equivalent technical field).
7–10 years of strong pharmaceutical assembly and packaging equipment knowledge.
Extensive experience with structured problem‑solving and troubleshooting techniques.
Advanced computer skills and proficiency in complex computer tasks and various programs.
Professional proficiency in speaking, reading, and writing fluently and accurately on all levels.
Strong analytical and decision‑making skills.
Exceptional time management, organizational, and negotiation skills.
Excellent communication and presentation skills; ability to motivate and lead teams by influence.
Strong financial acumen and analytical skills.
Highest reasoning ability and ability to apply principles of logical or scientific thinking.
Ability to travel.
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Quality Technician – Stamullen
Responsibilities
Generate packaging instructions, batch packaging records and labels for use in production from master documents.
Perform AQLs as required during production operations.
Sampling, approval and release of incoming goods, packaging materials and product (where required) for use in production.
Request certificates of analysis/conformance for incoming goods, packaging materials and product from customers/suppliers; review and file them.
Review and file stock cards, approval forms, equipment LUMAC logs and other production logbooks.
Identify training needs in conjunction with the production manager and conduct staff training as required.
Assist with environmental monitoring procedures, update spreadsheets to facilitate trending of results.
Ad‑hoc checks, in‑process checks and documentation review on a routine basis on production lines.
Approve line clearance procedures and pre‑production samples.
Maintain batch documents and retain samples in archive; update the PQR database after QP release.
Liaise with customers/suppliers for artwork‑related queries and approval of artwork.
Raise deviations, corrective action requests, non‑conformance reports as required and communicate them to the QC manager/designee.
Ensure activities are compliant with cGMP requirements.
Assist in performing validation studies.
Ensure safe work practices are being followed at all times; report defects immediately to the Safety Officer.
Carry out other additional tasks as required to support company goals.
Essential
Degree and/or relevant experience.
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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