Senior QA Batch Release Inspector

About the role

The Senior QA Batch Release Inspector ensures that finished pharmaceutical products are released to market in compliance with Abbott policies, SOPs, and regulatory requirements. The role involves thorough audit of batch documentation, coordination with cross‑functional teams, and adherence to cGMP standards.

Key responsibilities

• Audit and review batch manufacturing and packaging documents in Darius and BPCS.
• Release finished products for market distribution after confirming compliance with local regulations and site SOPs.
• Resolve documentation discrepancies promptly to avoid product delays.
• Issue batch‑related labels and ensure required stability or microbiological sampling is completed.
• Develop, draft, and review SOPs related to QA functions.
• Train new QA associates and conduct periodic Good Documentation Practices sessions.
• Perform BPCS transactions for hold, release, or reject decisions.
• Collect and share quality metrics, support APQR preparation, and drive continuous improvement initiatives.
• Participate in GEMBA inspections of warehouse, utilities, and facilities.

Required profile

• Senior‑level experience in pharmaceutical batch release or quality assurance.
• Strong knowledge of cGMP, regulatory requirements, and Abbott quality standards.
• Proven ability to work with cross‑functional teams and manage documentation workflows.
• Excellent analytical and problem‑solving skills.

Required skills

• BPCS (Batch Production Control System)
• Darius (batch documentation system)
• cGMP compliance
• SOP development and maintenance
• Good Documentation Practices (GDP)

What we offer

• Opportunity to work within a global pharmaceutical leader.
• Engagement in continuous improvement projects.
• Professional development and training programs.