Process Lead - Equipment Lifecycle

Job Summary:

Perform utilities/ equipment and facilities validation and qualification activities as per approved procedure/s in adherence to GxP regulations/guidelines.

Main Responsibilities:

1. Responsible for the HVAC Qualification. Experienced in the qualification approach of heating ventilation and Air conditioning, the qualification requirements for Area Classification, Uni-directional air flow, pass-boxes, weighing booth etc, in addition to facility qualification.
2. Responsible for the Equipment Qualification, follows the V-Model Approach for the Qualification of Equipment. Involved as Subject matter Experts for the URS Review, Define Risk assessment approach during the Initial Qualification phase.
3. Preparation of Project Validation plan. Work with Cross -functional team for the smooth execution work. Preparation of System release plan & traceability Matrix after completion of qualification phases.
4. Responsible for the execution and review of Air flow pattern studies in the classified rooms, UDAF &weighing booths.
5. Preparation and review of validation deliverables like User Requirements Specification (URS), Quality Risk assessment (QRA), GxP assessment, Functional Requirement Specification, DS, FRA, IQ, OQ, PQ, Design traceability Matrix, and summary validation Report etc.
6. Responsible for the Qualification of water system used in pharmaceutical companies (Purified water, Water for injection, Pure Steam) as well as compressed gasses.
7. Responsible for executing validation activities for GxP and computerized systems like SCADA, BMS Systems in HVAC and water systems according to the GAMP5 Validation Life Cycle for the Utilities. etc.
8. Prepare risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols.
9. Responsible for preparation, review and closure of test incidents/defects and its status reporting.
10. Perform periodic review or Re-qualification of the utilities & GxP systems to ensure that they continue to remain validated.
11. Work with area owner(s) to ensure the initiation and implementation of scheduled activities for the Qualification.
12. Handling of Validation system related QMS like deviations, change controls and CAPA’s etc.
13. Responsible for management for validation documents like archiving, retrieving and distribution.

Qualifications / Key Experiences / Functional Knowledge Requirements

• 8-10 years in pharmaceutical industry in validation & qualification sections in core pharmaceutical manufacturing plant is preferred.
• Knowledge of regulatory guidelines relevant to EU GMP, FDA, WHO guidelines and ISPE GAMP guidelines are required.
• Solid understanding of Engineering systems, Computer Systems Validation and, Quality
• Real Time Experience in the companies having GMP approval from USFDA/MHRA/TGA/ANVISA/EU authorities.