QA Engineering For Nagpur Location OSD Plant

Job Purpose:

To ensure compliance of all engineering systems, utilities, and equipment with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality standards. The Engineering QA Engineer will support qualification, validation, and periodic review activities to maintain a state of control across all engineering systems within the pharmaceutical manufacturing facility.

Key Responsibilities:

1. Qualification & Validation

Review and approve engineering qualification documents (URS, DQ, IQ, OQ, PQ) for equipment, utilities, and facilities.

Participate in qualification/validation activities ensuring compliance with cGMP and internal procedures.

Ensure traceability between design, risk assessment, and qualification deliverables.

Support requalification and revalidation activities as per the approved schedule.

2. Documentation & Compliance

Review and approve preventive maintenance (PM) and calibration records for compliance.

Participate in change control, deviation, CAPA, and risk assessment processes related to engineering systems.

Ensure all engineering activities comply with cGMP, GEP (Good Engineering Practices), and regulatory guidelines (USFDA, EU, WHO, MHRA, etc.)

3. Audit & Inspection Support

Prepare and support internal, external, and regulatory audits.

Respond to audit observations related to engineering systems and ensure timely closure of corrective actions.

4. Continuous Improvement

Identify opportunities for improvement in equipment reliability, qualification, and documentation practices.

Support training and awareness programs for engineering and operations teams on EQA procedures and GMP compliance.

5. Cross-functional Coordination

Work closely with Engineering, Production, Quality Control, and Quality Assurance departments to ensure smooth execution of projects and compliance activities.

Provide QA oversight during equipment installation, maintenance, and modification.

Qualifications and Experience:

Education: B.E./B.Tech in Mechanical / Electrical / Instrumentation / Chemical Engineering or related discipline.

Experience: 4 - 6 years of experience in Engineering QA / Validation / Qualification functions in a regulated pharmaceutical or biopharmaceutical manufacturing environment.

Technical Skills:

Good understanding of GMP, GEP, and regulatory guidelines.

Knowledge of HVAC, purified water systems, clean utilities, and process equipment.

Experience in equipment qualification and validation documentation.

Familiarity with deviation, change control, and CAPA systems.

Share cv at :- NeetiJ@selectsourceintl.com