Location (State / UT)
Experience8 Years, 12 Years
Desired QualificationBachelor Degree
Salary in (₹)Negotiable
- Responsible to perform qualification and validation activities of all pharmaceutical laboratory equipment.
- Responsible to perform System audit trail and user management periodic review
- Must have experience in equipment/instrument qualification/validation of 8-12 years in the pharmaceuticals industry.
Role & Responsibilities:
- Must be familiar with IQ/OQ/PQ execution and developing qualification protocols for Analytical equipment/instruments
- Should be familiar with identifying qualification deliverables as per AIQ.
- Should be familiar with DI/ERES concepts
- Should possess in-depth knowledge of Periodic review concepts and requirements.
- Should have a working knowledge of laboratory equipment like Chromatography systems (HPLC, GC, UPLC, etc), MS, Titrators, Balances, Autoclaves, stability chambers, lyophilized, etc.
- Must possess good knowledge of Enterprise software like Empower, Chromeleon, etc
- Responsible to coordinate with vendors for qualification/commissioning
- Responsible for designing calibration, and preventive maintenance schedules based on equipment complexity.
- Responsible to maintain Equipment qualification-related documents for Audit purposes.
- Should be able to perform periodic Audit trails and user management reviews for computerized and Non-computerized systems.
- Must possess Knowledge on GxP concepts
- Must be familiar with Handling Deviations/Incidents, Change controls, Investigations, etc in the Trackwise system.
- Should possess In-depth knowledge of 21CFR part 11 compliance and requirement
- Knowledge of analytical equipment calibration and maintenance will be an added advantage.
- Must be familiar with regulatory requirements like 21 CFR, annexure 11, etc.. and GAMP concepts.
- Should possess good negotiation skills.
- Possessing knowledge of Asset Manager would be added advantage.
- Bachelor’s Degree and 8-12 years of experience.
- Excellent communication skills and ability to deliver effective presentations to a variety of audiences.
- Ability to build relationships with internal and external stakeholders to influence outcomes.
- High proficiency in Word, Excel and have demonstrated an aptitude for computerized systems.
- Knowledge of GMP regulations/guidance (21 CFR Parts 11, 210 & 211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry.
- Background in problem-solving, negotiations, data integrity principles, and project management/support in a matrixed reporting environment.
- Good understanding of risk management methodologies, with a proven ability to apply to Bio-pharmaceutical operations.