Job Description

Position Summary:


The main purpose of this job is to ensure that all equipment used in pharmaceutical manufacturing meets regulatory requirements and is validated for its intended use. This includes ensuring that equipment used in various pharmaceutical processes (such as solid dosage forms, semi-solids, oral liquids, sterile areas) meets the necessary qualifications and standards. The role is crucial for maintaining compliance with regulatory bodies (such as SFDA, WHO, EU, USFDA) and ensuring that pharmaceutical manufacturing facilities operate in accordance with Good Manufacturing Practices (cGMP).


Main Responsibilities:


• Responsible for Equipment Qualification. Executing the Qualification deliverables for initial Qualification i.e Installation Qualification, Operational Qualification & performance Qualification.
• Responsible for the Equipment Qualification pharmaceutical Equipment's for Oral solid Dosage form (for Examples : Granulators, Compression, FBD, Coaters & Blister packaging etc) Semi-Solids & Oral Liquids (Manufacturing Vessels, Filling lines , labelling ,Packaging Lines) , Sterile area (Autoclave, Tunnel, Vial Filling line, Inspection machine, Lyophiliser etc) .
• 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.
• Responsible for the Qualification of Facilities used in pharmaceutical companies.
• Responsible for the temperature mapping of Cold Stores & Temperature Controller Chambers.
• Responsible for executing validation activities for GxP and computerized systems like Systems in according to the GAMP5 Validation Life Cycle for the Equipments. etc.
• Responsible for preparation, review and closure of test incidents/defects and its status reporting.
• Perform periodic review or Re-qualification of the Equipments & GxP 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.


Core Competency




• In terms of competency, you are highly result-oriented with an intense sense of accountability & ownership.
• High compliance adherence, having strong diligence, initiative-taking, and flexibility.
• Excellent communication, interpersonal, and collaboration skills.
• Having a demonstrated skill in leadership and people management
• Motivated, organized, focused & overall compliance.
• Must be able to manage tasks, plan workload effectively, prioritize, and easily adapt to changing situations.
• Ability to understand new learnings and implant them in the workplace.






Qualification/Functional Knowledge




• Bachelor of pharmacy/Science with minimum work experience of 3-5 years.
• Well experience on SFDA, WHO, EU & USFDA audit exposure.
• Good Computer knowledge and knowledge of QMS system "Agile, Track wise, Amplelogic."
• Proficient in English.
• Demonstrated solid experience in problem-solving and team management.
• Good Knowledge and command of cGMP
• Risk Assessment knowledge.