Senior Quality Assurance Specialist Hybrid Opportunity
We are currently recruiting for a senior quality assurance specialist position in a hybrid capacity with an award-winning pharmaceutical organization. This role is ideal for professionals seeking to join a leading multinational company that excels in its field.
Key Responsibilities:
* Provide overall quality direction for processes and procedures associated with technology transfer, NPI, and product lifecycle changes.
* Act as the Quality point of contact and decision-maker during technology transfer and PPQ execution activities, ensuring all activities comply with regulatory and company standards.
* Quality review and approval of validation documentation, including Design Specifications (DS), User Requirements Specifications (URS), and Quality Risk Assessments (QRAES).
* Validation Plans, Protocols (IQ, OQ, PQ), and associated reports.
* Ensure robust and compliant validation documentation to support site activities.
Risk Management: Conduct risk assessments and develop mitigation strategies for potential challenges in process transfers.
Provide input and quality oversight for change control development and implementation. Ensure timely and robust implementation of change controls and CAPA records.
Quality review and approval of Bill of Materials (BOMs), Master Batch Records (MBRs), and production recipes.
Collaborate with cross-functional teams to optimize processes and ensure successful scale-up and commercial manufacturing.
Write, review, and approve Standard Operating Procedures (SOPs) in alignment with policies.
Ensure all activities align with safety standards, SOPs, and regulatory expectations.
Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.
Requirements:
* University degree in a Science or Engineering-related discipline.
* Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.
* Proven expertise in technical transfer, PPQ execution, and lifecycle management.
* Strong understanding of validation principles and regulatory requirements for process validation (FDA, EMA guidelines).
* Experience with change control, non-conformance resolution, and CAPA implementation.