: Hybrid but required to be flexible in this regard Need experience in sterile or aseptic environment - min 3 years but ideally more Supervisor – Quality Assurance Team Lead.
Duties and Responsibilities:-Batch Record Review and material release (including Co A) to ensure compliance with GMP requirements.-Quality review and approval of Master Batch Record(MBR) record for routine cleaning and process activities,including Automation recipe updates.-QA Review and Approval of SOPs, Work Instructions andforms from other departments.-Attendance at Daily/Weekly Operations led Team Meetings.-Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a QA perspective.-QA review and approval of Warehouse Shipping Picklist.-Primary QA point of contact for Quarantine Shipments.-Responsible for Batch Book Filing & Archival.-QA review and approval of quality non-conformance(NC) records and customer complaint non-conformancerecords.-Initiation and ownership of QA non-conformancerecords.-Responsible for periodic review of Quality Assuranceand Quality Systems SOPs.-Primary Quality point of contact for attendance at Root Cause Analysis meetings.-Primary QA point of contact for the Returns process.
Minimum Requirements: Key Skills and Competencies Required:-Buildsstrong productive relationships.-Demonstrates ability to work with teams and individuals.-Seeks opportunities to grow and develop professionally.-Uses best practices to improve business operations.-Holds self-accountable for compliant and flawlessexecution.-Takes personal responsibility for decisions thatsuccessfully build customer value.-Effectively manages and adapts to change.-Always demonstrate Integrity and Credo-based actions.-Ability to work independently, manage their own time andmeet deadlines as appropriate.
Education and Experience:-Thirdlevel Degree in a science or pharmaceuticaldiscipline.-A minimum of 3 years of experience within the Pharmaceutical Industry.-A working knowledge of quality processes and systemsis desirable.-Demonstrated knowledge and application of industryregulations including those of FDA, HPRA, EMEA andother authorities.
NOTEWe are hiring for our clients diversability programme, so candidates with physical and hidden disabilities, mental health conditions or neurodivergence are invited to apply.
If you don't have a disability we can still register you for our traditional Source Pro hiring programme.
Source Abled, a proprietary workforce solution powered by Rangam, goes beyond a traditional job placement program.
It provides a collaborative, holistic solution implemented to develop an inclusionary program and a culture of belonging by matching Fortune 500 companies with diverse talent seeking to build and sustain successful and fulfilling careers.
Source Abled connects individuals with autism, neurodivergence and physical disability, to apply for jobs with employers in the USA, UK, Ireland, Europe and India, who are actively seeking talents with disabilities.
Source Abled facilitates the coordination and management of diverse hiring programs, with a consultative approach, including training, and brings them to life through digitizing the experience of attracting, onboarding, supporting, and retaining qualified employees with autism and disabilities.
The program uses an end-to-end, tech-enabled hiring program to build a connected inclusive community in the workplace for neurodivergent talent.
It is designed to attract and place qualified job seekers as businesses look to establish, build, and maintain their disability inclusion practices and establish and nurture a culture of inclusion.
It is the policy of Rangam Consultants, Inc.
to provide equal employment opportunities to all applicants and employees without regard to any legally protected status such as race, color, religion, gender, national origin, age, disability or veteran status.
Job Type: Full-time Pay: €40.00 per hour Expected hours: 40 per week Application question(s): Experience in sterile or aseptic environment?GMPSOPEducation: Bachelor's (preferred)Work authorisation: Ireland (required)Willingness to travel:75% (required)Work Location: In person