QA Senior Specialist (7168)

Senior Quality Assurance Role in Pharmaceutical Manufacturing

Join a leading company in the pharmaceutical industry to support project-specific Quality Assurance activities during commissioning, qualification, and technology transfer. This eight-month contract role focuses on ensuring GMP compliance, providing operational QA support, and collaborating closely with cross-functional teams to maintain quality standards throughout manufacturing and project activities.

Key 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 and 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.