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.
Qualifications
Must-Have:
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.
