Quality Assurance Manager

1. Position Overview

3+ years of QA experience

2. Key Responsibilities

A. GMP Compliance & Quality Systems

• Monitor GMP and GDP compliance on the shop floor.
• Support management of deviations, change controls, CAPA, and risk assessments.
• Assist in internal audits and help ensure timely closure of audit findings.

B. Batch Documentation & Release Activities

• Review BMRs and BPRs for completeness and compliance.
• Coordinate with Production and QC for smooth batch release.
• Ensure proper maintenance of logbooks and adherence to data integrity practices.

C. SOP & Documentation Management

• Draft, revise, and maintain SOPs and controlled documents.
• Ensure Good Documentation Practices (GDP) across departments.
• Manage document control systems under the guidance of the Head of Quality.

D. Material & Vendor Support

• Review COAs, vendor documents, and relevant technical data.
• Support Procurement and QC in vendor qualification processes.
• Participate in supplier assessments when required.

E. Training & Compliance Support

• Conduct basic GMP and documentation training for staff.
• Monitor routine compliance in production, stores, and QC.
• Escalate non-compliances and initiate corrective actions.

F. Investigations & CAPA Coordination

• Assist in investigations related to deviations, OOS/OOT, and product complaints.
• Ensure CAPAs are documented, followed up, and closed within timelines.

G. Cross-Functional Coordination

• Work with Production, QC, Stores, and Engineering to resolve quality issues.
• Provide QA support during equipment qualification, validation, and line clearance activities.

3. Skills & Competencies

• Strong understanding of GMP, GDP, and basic QMS elements.
• Good knowledge of nutraceutical/pharmaceutical operations (softgels beneficial).
• Strong documentation and compliance-monitoring capabilities.
• Good communication, training, and coordination skills.
• Ability to handle routine QA tasks independently while escalating major issues appropriately.
• Familiarity with FSSAI, WHO-GMP, or AYUSH requirements is preferred.

4. Qualifications & Experience

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or equivalent.

• Minimum 3 years of experience

  in QA within pharmaceutical or nutraceutical manufacturing.
• Experience in batch documentation review and basic compliance activities.
• Exposure to audits or regulatory inspections is an added advantage.