Manager / Senior Manager - QA

Role & responsibilities

• Provide oversight and approval for Quality Management System (QMS) elements including Deviations, OOS, OOT, CAPA, Change Controls, Risk Assessments, Complaints, Recalls, and Returned Goods.
• Ensure timely investigation, closure, and effectiveness verification of quality events.
• Authorize release or rejection of Intermediates, and APIs in accordance with approved specifications and GMP requirements.
• Ensure compliance of manufacturing processes with approved procedures and regulatory expectations.
• Review and approve SOPs, specifications, batch manufacturing records, analytical records, protocols, reports, and other GMP documents through electronic quality systems.
• Ensure robust documentation practices and adherence to Data Integrity principles.
• Review and approve validation protocols and reports, including Process Validation, Cleaning Validation, Equipment Qualification, Utility Qualification, and Computerised System Validation.
• Review and approve quality risk assessments associated with manufacturing processes and systems.
• Ensure compliance of calibration and preventive maintenance programs from a quality perspective.
• Lead the IPQA team, Ensure effective shop-floor QA oversight and escalation of critical observations.
• Lead and participate in regulatory agency inspections, customer audits, and internal audits.
• Coordinate audit preparations and ensure timely closure of observations through effective CAPA implementation.
• Conduct self-inspections and compliance assessments to identify and mitigate quality risks.
• Provide quality guidance for new projects, process improvements, and operational excellence initiatives.
• Coach and mentor team members to strengthen quality systems and compliance culture.
• Drive continuous improvement and quality culture initiatives across the site.
• Act as Head-QA designee in their absence and assume responsibility for all site QA activities.

Preferred candidate profile

• Must have experience in API (Active Pharamacetuicals Ingredients ) manufacturing, with preference given to candidates having exposure to peptide manufacturing.
• Strong exposure to Quality Management Systems (QMS) including Deviations, OOS, OOT, CAPA, Change Controls, Risk Assessments, Complaints, Recalls, and Returned Goods.
• Sound knowledge of cGMP, Data Integrity, and Regulatory Compliance requirements.
• Experience in review and approval of SOPs, BMRs, analytical records, specifications, protocols, reports, and validation documents.
• Expertise in Process Validation, Cleaning Validation, Equipment Qualification, Utility Qualification, and Computerized System Validation (CSV).