Description
QA Senior Specialist – 7168
Our client, a leading company in the pharmaceutical industry, is looking for a QA Senior Specialist to support project-specific Quality Assurance activities during commissioning, qualification and technology transfer activities.
The successful candidate will ensure GMP compliance, provide operational QA support and collaborate closely with cross-functional teams to maintain quality standards throughout manufacturing and project activities. It's a 8 months contract.
Responsibilities
- Lead and support project-specific QA activities during commissioning, qualification and technology transfer.
- Assess, manage and coordinate quality-related activities that may impact GMP manufacturing operations.
- Plan and coordinate upcoming quality activities in collaboration with QC, Engineering, Manufacturing and other relevant departments.
- Provide day-to-day Quality Assurance support within a GMP manufacturing environment, ensuring compliance with approved SOPs and quality policies.
- Review GMP documentation and manufacturing records to ensure compliance with cGMP requirements and established procedures.
- Make real-time quality decisions regarding process events and deviations on the manufacturing floor, based on applicable SOPs and quality policies.
- Participate in facility walkthroughs, internal audits and regulatory inspections.
Required Skills & Qualifications
- Bachelor's degree in Life Sciences or a related scientific discipline.
- Significant experience in Quality Assurance within the pharmaceutical industry.
- Previous experience in QA, Production or Engineering within a pharmaceutical GMP-controlled environment.
- Experience supporting technology transfer activities is highly preferred.
- Excellent knowledge of computerized systems such as TrackWise and SAP.
- Good understanding of quality risk management tools and methodologies, particularly FMEA.
- Strong coordination and communication skills, with the ability to collaborate effectively across multiple departments.
- Fluent in English.