Executive QA (Sterile Qualification)

Department: Quality Assurance Qualification & Validation
Experience: 510 Years
Qualification:

- B.Pharm / M.Pharm / M.Sc. (Microbiology, Biotechnology, Chemistry) / B.E. or B.Tech
- Certification in GMP, Validation, or Quality Systems is desirable.

Job Summary

The Executive QA (Sterile Qualification) is responsible for planning, executing, reviewing, and maintaining qualification activities for sterile manufacturing facilities, equipment, utilities, and computerized systems. The role ensures compliance with cGMP, regulatory requirements, data integrity principles, and company quality standards while supporting validation and qualification programs for sterile injectable manufacturing.

Key Responsibilities

Equipment Qualification

- Prepare, review, execute, and approve IQ, OQ, PQ protocols and reports for manufacturing and packaging equipment.
- Coordinate qualification activities for new equipment, modifications, and relocations.
- Ensure equipment qualification is completed in accordance with validation master plans and regulatory expectations.

Facility & Utility Qualification

- Perform qualification of cleanrooms and classified manufacturing areas.
- Support qualification of HVAC systems, compressed gases, purified water (PW), Water for Injection (WFI), clean steam, and other critical utilities.
- Review qualification data and ensure compliance with acceptance criteria.

Process Support

- Support Process Validation, Media Fill Validation, Cleaning Validation, and Hold Time Studies.
- Participate in Technology Transfer activities and qualification of new manufacturing lines.
- Verify readiness of equipment and utilities before validation execution.

Documentation & Compliance

- Prepare and review qualification protocols, reports, SOPs, risk assessments, and validation documents.




- Ensure documentation complies with GDP and ALCOA+ data integrity principles.
- Maintain validation lifecycle documentation and periodic review records.

Regulatory Compliance

- Ensure qualification activities comply with cGMP, Schedule M, US FDA, EU GMP Annex 1, WHO GMP, PIC/S, and company quality standards.
- Participate in internal, customer, and regulatory audits.
- Support closure of audit observations related to qualification and validation.

Deviation, CAPA & Change Control

- Investigate deviations occurring during qualification activities.
- Support root cause analysis and implement CAPAs.
- Assess qualification impact during Change Control implementation.
- Participate in risk assessments (FMEA/QRM).

Calibration & Maintenance Coordination

- Coordinate with Engineering and Maintenance departments to ensure equipment calibration and preventive maintenance are completed before qualification.
- Verify calibration status of critical instruments.

Cross-Functional Coordination

- Work closely with Production, Engineering, QC, Microbiology, Validation, and Regulatory Affairs teams.
- Coordinate qualification schedules to minimize production downtime.

Required Technical Skills

- Strong knowledge of Equipment Qualification (IQ/OQ/PQ).
- Experience in HVAC Qualification and Cleanroom Qualification.
- Knowledge of Utility Qualification (PW, WFI, Clean Steam, Compressed Air, Nitrogen).
- Understanding of Sterile Injectable Manufacturing processes.




- Familiarity with Process Validation and Cleaning Validation.
- Positive knowledge of cGMP, GDP, Data Integrity (ALCOA+), and Quality Risk Management (ICH Q9).
- Understanding of Annex 1 requirements for sterile manufacturing.
- Proficiency in Microsoft Office and electronic Quality Management Systems (eQMS).

Behavioral Competencies

- Strong analytical and problem-solving skills.
- Good technical writing and documentation skills.
- Excellent communication and teamwork.
- Attention to detail and commitment to quality.
- Ability to manage multiple qualification projects simultaneously.
- Strong planning and organizational abilities.

Preferred Experience

- Experience in sterile injectable or aseptic manufacturing facilities.
- Hands-on exposure to qualification of isolators, RABS, autoclaves, depyrogenation tunnels, sterilizers, lyophilizers, filling machines, and CIP/SIP systems.
- Experience supporting US FDA, EU GMP, MHRA, WHO GMP, or PIC/S regulatory inspections.
- Knowledge of computerized system validation (CSV) is an added advantage.

Key Performance Indicators (KPIs)

- Timely completion of qualification and validation activities.
- On-time execution of IQ/OQ/PQ protocols and reports.
- Zero critical audit observations related to qualification.
- Timely closure of deviations, CAPAs, and change controls.
- Compliance with Validation Master Plan (VMP).
- Successful support of regulatory inspections and customer audits.
- Documentation accuracy and adherence to GDP requirements.
- Continuous improvement in qualification and validation processes.

This JD is well suited for Executive-level QA professionals (5–10 years) working in sterile injectable pharmaceutical manufacturing and aligns with the expectations of US FDA, EU GMP Annex 1, WHO GMP, PIC/S, and Schedule M regulated facilities.

📌 QA - Qualification Executive (South Goa)
🏢 Indoco Remedies
📍 South Goa