Job Opportunities in United Arab Emirates
August 21, 2024
Julphar
Process Lead - Equipment Lifecycle
Job Summary:
Perform utilities/ equipment and facilities validation and qualification activities as per approved procedure/s in adherence to Gx P regulations/guidelines.
Main Responsibilities:
Qualifications / Key Experiences / Functional Knowledge Requirements
Perform utilities/ equipment and facilities validation and qualification activities as per approved procedure/s in adherence to Gx P regulations/guidelines.
Main Responsibilities:
- 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.
- 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.
- 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.
- Responsible for the execution and review of Air flow pattern studies in the classified rooms, UDAF &weighing booths.
- Preparation and review of validation deliverables like User Requirements Specification (URS), Quality Risk assessment (QRA), Gx P assessment, Functional Requirement Specification, DS, FRA, IQ, OQ, PQ, Design traceability Matrix, and summary validation Report etc.
- Responsible for the Qualification of water system used in pharmaceutical companies (Purified water, Water for injection, Pure Steam) as well as compressed gasses.
- Responsible for executing validation activities for Gx P and computerized systems like SCADA, BMS Systems in HVAC and water systems according to the GAMP5 Validation Life Cycle for the Utilities. etc.
- Prepare risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols.
- Responsible for preparation, review and closure of test incidents/defects and its status reporting.
- Perform periodic review or Re-qualification of the utilities & Gx P systems to ensure that they continue to remain validated.
- Work with area owner(s) to ensure the initiation and implementation of scheduled activities for the Qualification.
- Handling of Validation system related QMS like deviations, change controls and CAPA’s etc.
- Responsible for management for validation documents like archiving, retrieving and distribution.
- 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.
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