Urgent Hiring For Senior Quality Assurance For Merchant Exports

Job Profile: Senior Executive/Manager - Quality Assurance (QA) - Merchant Exports

Overview

The Quality Assurance Manager for Merchant Exports is responsible for establishing, maintaining, and overseeing a robust Quality Management System (QMS) across all outsourced manufacturing, testing, and distribution operations for a diversified portfolio of finished pharmaceutical formulations (tablets, capsules, liquids, etc.). This role ensures that all products comply with international regulatory standards (e.g., WHO-GMP, EU-GMP, US-FDA cGMP) and the specific requirements of the importing countries.

Key Responsibilities

I. Supplier/Facility Qualification and Management (Vendor Audits)

Audit Management: Plan, conduct, and lead qualification and periodic GMP/Quality audits of third-party Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories, and packaging vendors across different geographical locations and product ranges.

Quality Agreements: Draft, negotiate, and finalize comprehensive Quality Agreements with all approved vendors, clearly defining responsibilities for manufacturing, testing, change control, deviation handling, and documentation.

Supplier Monitoring: Establish and maintain a vendor rating and performance monitoring system based on key quality metrics (e.g., batch failures, OOS rates, compliance status).

II. Documentation and Batch Release

Batch Record Review (BMR/BPR): Perform the final, thorough review of Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) from CMOs for completeness, accuracy, and compliance with the approved Master Batch Records and cGMP standards.

Product Disposition: Take final QA approval for the release or rejection of finished product batches destined for international markets.

Regulatory Documentation: Ensure all site-specific documentation (SOPs, Validation Protocols/Reports, Calibration Records) are reviewed and compliant with relevant Good Manufacturing Practice (GMP) guidelines prior to batch release.

Artworks and Labeling: Review and approve all finished product artworks, labels, and packaging materials to ensure accuracy and compliance with country-specific registration details.

III. Quality Management System (QMS) Oversight

Change Control: Manage the Change Control system for all outsourced products (changes to materials, processes, specifications, or documents), ensuring all changes are assessed for regulatory impact and implemented effectively at the CMO site.

Deviation and CAPA Management: Oversee the investigation of critical Deviations, Out-of-Specification (OOS), and market complaints originating from the CMOs, ensuring root cause analysis is performed and effective Corrective and Preventive Actions (CAPAs) are implemented and tracked for closure.

Product Quality Review (PQR): Review and consolidate Annual Product Quality Review (PQR) data from CMOs for multiple products to identify quality trends and drive continuous improvement.

IV. Regulatory Compliance and Distribution

Regulatory Liaison: Support the Regulatory Affairs team by providing necessary GMP and facility documentation from CMOs for product registration and re-registration in target export markets.

Good Distribution Practices (GDP): Ensure compliance with GDP guidelines, overseeing and approving packaging, transport, and storage conditions, especially for temperature-sensitive products.

Self-Inspection/Internal Audit: Initiate and oversee internal audits of the merchant exporter's own quality processes and supply chain.

Required Qualifications and Skills

Education

Essential: B.Pharm/M.Pharm or M.Sc. in Chemistry/Analytical Chemistry/Life Sciences.

Experience

Required: 5 to 10 years of progressive experience in Quality Assurance within a Pharmaceutical Finished Formulation manufacturing or merchant export compan