Commercial QA Specialist

Role Summary:

The Executive – Sterile Manufacturing & Quality Operations is responsible for supporting shop

floor sterile manufacturing activities while ensuring compliance with regulatory and quality

standards. The role involves cross-functional coordination for vendor qualification, risk

management, validation activities, and batch documentation review to maintain product quality

and operational excellence.

Key Responsibilities

1. Shop Floor Manufacturing Support

Understanding of aseptic fill finish / terminal sterilization process including its monitor

and support within the sterile manufacturing operations arena (aseptic processes, filling,

compounding, filtration and visual inspection).

Ensure adherence to cGMP, SOPs, and aseptic practices.

Participate in review of batch records and other associated records for completeness,

accuracy and compliance. Identify and escalate discrepancies or non-conformances

2. Vendor Qualification & Quality Systems

Assist in vendor qualification activities including audits, documentation review, and

risk-based assessments of all prospective suppliers and its requalification

Support preparation and review of Quality Agreements with vendors and contract

manufacturers.

Maintain vendor qualification records in compliance with regulatory expectations.

3. Risk Management

Conduct and document risk assessments (e.g., FMEA, QRM tools) for processes,

deviations, and changes.

Support implementation of risk mitigation strategies.

4. Deviations, Investigations & CAPA

Participate in review of deviation handling, root cause analysis, and investigation

reports.

Ensure timely closure of investigations with appropriate CAPA (Corrective and

Preventive Actions).

Track effectiveness of CAPA implementations.

Ensure documentation aligns with regulatory and internal quality standards.

5. Validation & Qualification Activities

Have a holistic understanding and hands on experience w.r.t Process validation,

Cleaning validation, Equipment qualification, Hold time studies

Commercial Quality Assurance Operations

Job Description

6. Compliance & Documentation

Ensure compliance with global regulatory requirements (USFDA, EU GMP, WHO,etc).

Maintain proper documentation practices (GDP).

Participate in internal and external audits and regulatory inspections.

Qualifications & Experience

Education: Bachelor's/Master's in Pharmacy, Life Sciences, or related field.

Experience: 6–10 years in sterile pharmaceutical manufacturing or quality operations.

Hands-on experience in aseptic manufacturing environments is mandatory.

Key Skills & Competencies

Strong understanding of sterile manufacturing processes and contamination control.

Knowledge of regulatory guidelines (cGMP, aseptic processing standards).

Experience with investigations, risk assessments, and validation activities.

Good documentation and analytical skills.

Cross-functional collaboration and communication skills.

Preferred Skills

Exposure to regulatory audits (USFDA, MHRA, etc.).

Familiarity with electronic quality systems (eQMS).

Certification or training in Quality Risk Management tools.

Reporting Structure

Reports to: Senior Executive / Manager – Quality Assurance