QA Operations Support Specialist

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization

About the Role

The QA Operations Support Specialist will provide practical support to the QP function, focused on batch release preparation, initial document review, packing release activities, and EU laboratory QMS support, temperature evaluations, and preparation of CoAs/CoCs.

The role also supports selected post-release and QMS activities, including change controls, deviations, PQR inputs, complaint trends.

Key Responsibilities

QP Support and Batch Release Preparation

• Prepare batch release documentation packs for QP review and certification.
• Perform initial review of biosimilar batch files, packing release records, CoAs/CoCs, temperature records, and supporting documents.
• Identify documentation gaps or potential release concerns and escalate to QA/QP.
• Maintain release trackers and follow up actions to support timely batch progression.
• Raise and coordinate change controls and deviations under QA guidance.
• Support QP-related QMS inputs, including PQRs, complaint trends, metrics, and routine review materials.
• Assist with EU laboratory QMS documentation and follow-up activities.
• Prepare temperature evaluation summaries and escalate exceptions for QA/QP assessment.
• Review and streamline QMS functions as part of continuous improvement within the Organization.

About You

The ideal candidate is a self-motivated QA professional with biosimilar batch file review experience, strong coordination skills, and an interest in progressing towards QP education.

Key Interfaces

• QP, QA Operations, QC laboratories, Supply Chain, Regulatory Affairs, Packaging, EU laboratories, and relevant internal QMS stakeholders.

Qualifications and Experience

• Degree in pharmacy, chemistry, biology, biotechnology, pharmaceutical sciences, life sciences, or related discipline.
• Typically 10+ years’ experience in QA, batch review, QA operations, or QMS support.
• Experience with biosimilar batch file review and GMP/GDP documentation.
• Progressing towards, or interested in, education aligned with the QP pathway.

Skills and Competencies

• Strong attention to detail and ability to identify documentation gaps.
• Good coordination, follow-up, and Prioritization skills.
• Clear written and verbal communication.
• Self-motivated, Organized, and able to escalate appropriately.

Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.