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Pharmaceutical Quality Assurance Specialist
2 weeks ago
Job Title: Pharmaceutical Quality Assurance Specialist
The role of a Pharmaceutical Quality Assurance Specialist is to ensure that medicinal products are manufactured and distributed in compliance with regulatory requirements.
Responsibilities include:
- Providing quality and compliance guidance on critical and major quality matters;
- Providing quality direction and guidance for projects related to processes, product, and compliance;
- Providing quality oversight of quality management system, procedures, release, and compliance documents including CAPAs (Corrective and Preventive Action), Deviation Management, Change Controls, and Quality Agreements;
- Ensuring all necessary manufacturing, packaging, and associated documentation has been completed and endorsed by suitably authorized staff;
- Ensuring independence of the QP (Qualified Person) on decisions on quality-related matters;
- Providing support with investigations and resolution of discrepancies;
- Providing audit support as required for client Health Authority Inspections, internal auditing program, and supplier audits;
- Supporting clients in continuous improvement initiatives for GMP compliance;
- Participating in cross-functional teams to provide consultative support on quality-related issues;
- Maintaining an up-to-date knowledge of pharmaceutical legislation and industry practice;
- Supporting Quality/Compliance/Regulatory (QCR) CAI business area lead (BAL) with the achievement of Objectives and Key Results (OKRs).
Requirements include:
- Third-level qualification in a science-related discipline;
- Eligible and demonstrated ability to act as Qualified Person within EC/EEA;
- Minimum 3 to 5 years QP experience;
- Excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team-oriented approach;
- Extensive demonstrated pharmaceutical quality experience;
- Thorough knowledge of biopharmaceutical and/or pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements;
- Audit experience would be beneficial;
- Strong task management skills with the ability to prioritize, schedule, and control under tight deadlines.
We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global company. We pledge that our company will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.