**Position:** **Assistant Manager Validation** **Reporting to:** **Senior Validation Manager** **Division:** **Established Pharmaceutical Division** **- Operation** **Location:** **Karachi** **-Pakistan** **Job Summary:** 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 An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com