Assistant Manager Validation

JOB DESCRIPTION:

To liaise with Sr. Validation manager for providing support to Validation Review Board (VRB) and Validation Execution Team for Validation and Qualification activities related with Products, Processes, Equipment, Utilities, Facilities.

Major Responsibilities:

• Implementation and compliance of all the SOPs and EQD/AQR Policies and Procedures related with Validation/Qualification.
• Develop, review, and execute Cleaning Validation Protocols (IQ/OQ/PQ).
• Establish and justify MACO/Acceptance Criteria for product residues, detergents, and microbial contamination.
• Perform risk assessments for cleaning processes and equipment.
• Coordinate sample collection and ensure correct analytical testing (TOC, HPLC, swab/rinse analysis).
• Prepare Cleaning validation protocol, analyze validation results and prepare comprehensive Cleaning Validation Reports.
• Maintain and update the Cleaning Validation Master Plan (CVMP).
• Support qualification of equipment, utilities, and CIP/SIP systems.
• Investigate cleaning failures, deviations, and trends; implement CAPAs.
• Collaborate with Operations, Engineering, QA, and QC on continuous improvements.
• Ensure compliance with cGMP, FDA, EU EMA, ICH Q7, and internal standards.
• Train operators on cleaning procedures and validation practices.
• Participate in regulatory audits as the Cleaning Validation subject matter expert (SME).
• Performance of Validation/Qualification activities related with Products & Processes, Equipment’s, Utilities, Facilities.
• Performance of Revalidation/Re-Qualification activities as per Validation Master Plan.
• Approval and filing of Validation documentation (Validation Change Request, Design Qualification, Protocols, Reports etc.).
• Ensuring appropriate training of VRB and Validation Execution Team and keeping the records.
• Any other responsibility assigned by Sr. Manager Validation or Director QA.
• Planning and scheduling of cleaning validation activities incoordination with all concern department.
• Develop and maintain CSV deliverables: Risk assessments, validation plans, IQ/OQ/PQ protocols, test scripts, and summary reports.
• Perform 21 CFR Part 11 and Annex 11 compliance assessments for electronic systems.
• Manage system lifecycle documentation: system inventory, user access management, periodic reviews, change controls.
• Collaborate with system owners, IT, QA, and vendors during implementation and upgrades.
• Review and approve vendor documentation: FRS/DS, FAT/SAT, configuration specs.
• Support audit trails, backup/restore testing, and cybersecurity controls.
• Investigate system deviations, perform impact analysis, and support CAPAs.
• Provide SME support during regulatory inspections and internal audits.
• Ensure continuous compliance through system monitoring, revalidation, and periodic assessments.
• Preparation of Computer System Validation Master Plan, Periodic Review, Protocol and Report.

Education/Knowledge & Experience:

• Science Graduate/Master; preferably MSc Chemistry/Microbiology/Pharm D
• 4-5 years’ experience in the same capacity 
• Knowledge regarding Validation of Process, Equipment, Utility and Facility, preferably in a multinational Pharmaceutical.
• Proficient in MS Office
• High Analytical Skills
• Analytical Skills

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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