PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud‑based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
Take your Career to a new Level
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like‑minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure to working in Top Pharmaceutical client sites in a diverse cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech; we provide unparalleled empowering career development through Learning & Development in‑house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Summary
As part of establishing sterile filling operations at the facility, this role (which reports to the QA Operations Manager) will provide QA support for the start‑up of the facility, before moving into routine QA support of the same.
The successful candidate will also have proven capability in promoting Quality across cross‑functional teams, to deliver on‑time high quality processes and products, whilst ensuring continuous process improvement.
This is a shift role, 2 Shift Rotation (8hr).
Key Responsibilities
Provide Quality direction and oversight of the start‑up, technical transfer, operation, and continuous improvement of Sterile Drug Product Filling operations.
Provide Quality input to Change Controls, Protocols and Reports ensuring scope of records are clear and implementation activities are robust and timely.
Write, review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation in accordance with Policies.
Participate within inter‑departmental and cross‑functional project teams to immediately address issues and questions in real time to help ensure project timelines are achieved.
Prioritize tasks to ensure the critical tasks are completed on time and meet requirements.
Provide Quality input and guidance to ensure Lot Release (Components/Raw Materials/Drug Product) of high quality products in compliance with current Good Manufacturing Practices (GMPs).
Compile Lot Release Packs as per requirements of SOPs, WIs and related FRMs.
Provide Quality input to Deviations ensuring scope of record is clear and implementation activities are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
Exercise judgment to determine appropriate action, ensuring proper escalation when issues are identified as per applicable procedures for compliance, escalation and corrections.
Pro‑actively identify compliance risks and take appropriate preventative actions.
Proactively identify potential issues, lead root cause analysis, make recommendations and aid in implementation for more complex and non‑reoccurring issues.
Ensure high level of Quality / cGMP Awareness in the Project Team and Sterile Filling Team.
Lead Area GMP Certification Activities.
Support pre‑approval Regulatory Inspection readiness to ensure regulatory approvals are obtained.
Support all Quality Assurance elements needed to facilitate new product launches.
Qualifications & Experience - Knowledge & Skills Requirements
Required
Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage.
Demonstrated experience in Sterile Drug Product Filling and start‑up of same.
Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or another combination of experience and educational background that may otherwise satisfy the other requirements of the role.
Experience in QA is mandatory.
Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems.
Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels.
Strong organizational skills, including ability to follow assignments through to completion.
Proficiency in PC skills such as Excel, Word, PowerPoint.
Proven decision making capability with full accountability and responsibility.
Demonstrated coaching skills.
Excellent written and verbal communication skills.
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations.
Evidence of Continuous Professional Development.
Evidence of Validation knowledge/experience.
MES experience.
Good knowledge of Lean / Continuous Improvement practices and root cause analysis.
Behaviours
Always focused on the patient and customer needs.
Resilient profile with the ability to deliver in a challenging environment.
Ability to engage and manage multiple stakeholders to achieve the objective.
Curious with learning agility.
Operationally excellent, with attention to detail.
Organised with systematic approach to prioritisation.
Process orientated to achieve the business objective.
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