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** N/A In specific locations, the pay range may vary from the range posted. **JOB FAMILY:** --------------- Operations Quality **DIVISION:** ------------- EPD Established Pharma **LOCATION:** ------------- Pakistan > Karachi : Opp: Radio Pakistan Transmission, Hyderabad Road, Landhi **ADDITIONAL LOCATIONS:** ------------------------- **WORK SHIFT:** --------------- Standard **TRAVEL:** ----------- Not specified **MEDICAL SURVEILLANCE:** ------------------------- Not Applicable **SIGNIFICANT WORK ACTIVITIES:** -------------------------------- Not Applicable