⦁ Creating and maintaining Site Validation Master Plan (SVMP) in compliance with the group quality policies and regulatory requirements.⦁ Creating / facilitating validation protocols which fulfill current compliance requirements.⦁ Periodically reviewing validated manufacturing and filling process, equipment, utilities, facilities, cleaning processes in order to ensure that they remain in validated status. ⦁ Ensure that the trainings on validation related SOPs have been delivered in… Show more ⦁ Creating and maintaining Site Validation Master Plan (SVMP) in compliance with the group quality policies and regulatory requirements.⦁ Creating / facilitating validation protocols which fulfill current compliance requirements.⦁ Periodically reviewing validated manufacturing and filling process, equipment, utilities, facilities, cleaning processes in order to ensure that they remain in validated status. ⦁ Ensure that the trainings on validation related SOPs have been delivered in time to all the stakes holders. ⦁ Participating in audit preparation and related training ⦁ To keep Validation department in line with the GOPs and GQMPs related to Validation. ⦁ To provide validation support to the continuous improvement automation of corporate projects in an environment of rapid change⦁ To coordinate with multi-functional validation working party (VWP) in achieving validation targets as per defined time lines.⦁ To prepare data for update of validation activities for site Quality Council Meeting Show less

• Lead the validation activities as part of the facility design, build and qualification project by hands-on work and support from specialist contractor(s) as required.• Support FATs, SATs, IQ/OQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice.• Responsible for the oversight of ongoing (DQ, IQ, OQ, PQ) validation activities once production has commenced.• Review of vendor protocols and creation or approval of in-house… Show more • Lead the validation activities as part of the facility design, build and qualification project by hands-on work and support from specialist contractor(s) as required.• Support FATs, SATs, IQ/OQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice.• Responsible for the oversight of ongoing (DQ, IQ, OQ, PQ) validation activities once production has commenced.• Review of vendor protocols and creation or approval of in-house protocols and reports to deliver a complete package of qualification documentation.• As some validation activities will be outsourced, you will maintain these relationships, monitoring KPIs so that performance and value for money is maintained.• In addition to the contractors, manage other validation team member(s), including their performance, development, training and compliance.• Work effectively and supportively with other project team members to deliver the GMP manufacturing facility in accordance with the programme.• Draft and review GMP documentation including validation documentation, SOPs, and training documentation.• Understand the production schedule and work closely with Manufacturing and Engineering to build a qualification schedule that delivers minimum interruption to manufacturing output.• Participate in continuous improvement in the manufacturing facility to enable production to be conducted effectively and efficiently. Show less

⦁ Implementation and compliance of all the SOPs and EPO/AQR Policies and Procedures related with Validation/Qualification. ⦁ Preparation of Site validation master plan. ⦁ Preparation Validation Master Plan (VMP) of Oral solid dosage (OSD), oral liquid dosage (OLD), Semi solid dosage (SSD), Small volume parenteral (SVP), warehouse and Karachi Technical Center (KTC) ⦁ Perform Validation and Qualification activities related with Products, Processes, Equipment’s, Utilities, Facilities,… Show more ⦁ Implementation and compliance of all the SOPs and EPO/AQR Policies and Procedures related with Validation/Qualification. ⦁ Preparation of Site validation master plan. ⦁ Preparation Validation Master Plan (VMP) of Oral solid dosage (OSD), oral liquid dosage (OLD), Semi solid dosage (SSD), Small volume parenteral (SVP), warehouse and Karachi Technical Center (KTC) ⦁ Perform Validation and Qualification activities related with Products, Processes, Equipment’s, Utilities, Facilities, Cleaning validation. ⦁ Responsible for the Training of Validation Review Board (VRB) and Validation Execution Team. ⦁ Validation/Qualification studies other than the routine schedule like Plant Expansion Projects (Pakistan Technical Center) and Continuous Improvement Projects. ⦁ Preparation and Presentation of Validation Metrics (Status of Validation Activities) to EPO on quarterly basis. ⦁ Preparation and Presentation of QPR (Quality Performance Review) to EPO on monthly basis.⦁ Represent affiliate in Regional Validation Business Council Meetings. Show less

⦁ Archiving of Validation documentation (Validation and Qualification activities related with Products, Processes, Equipment’s, Utilities, Facilities, Cleaning validation.). ⦁ Raised Change Request related to validation activities.⦁ Archiving of Validation documentation (Validation and Qualification activities related with Products, Processes, Equipment’s, Utilities, Facilities, Cleaning validation.). ⦁ Preparation of Product Quality Review (PQR) of Products. ⦁ Preparation of QA… Show more ⦁ Archiving of Validation documentation (Validation and Qualification activities related with Products, Processes, Equipment’s, Utilities, Facilities, Cleaning validation.). ⦁ Raised Change Request related to validation activities.⦁ Archiving of Validation documentation (Validation and Qualification activities related with Products, Processes, Equipment’s, Utilities, Facilities, Cleaning validation.). ⦁ Preparation of Product Quality Review (PQR) of Products. ⦁ Preparation of QA Checklist for Request for Capital Expenditures (RCEs), Quality and Regulatory Issues and Action Plans (whenever required). ⦁ Provide Validation support to other sections of QA i.e., QA Documentation, QA System and Compliance, CAPA, PTC, etc. ⦁ Provide support in terms of Process Validation in the launch of new products. Show less

⦁ Perform In process test in all areas Tablet Compression, Tablet Filling, Tablet Finishing, Liquid Filling, Liquid Finishing, Injection Filling, Injection Finishing.⦁ Ensuring Production area operability⦁ Performing compression area tests; weight variation, dissolution test, hardness and thickness⦁ Preparing filling and finishing control data sheet⦁ Performing filling and finishing checks⦁ Ensuring Health Safety Hazards and Environmental Safety ProceduresPerforming… Show more ⦁ Perform In process test in all areas Tablet Compression, Tablet Filling, Tablet Finishing, Liquid Filling, Liquid Finishing, Injection Filling, Injection Finishing.⦁ Ensuring Production area operability⦁ Performing compression area tests; weight variation, dissolution test, hardness and thickness⦁ Preparing filling and finishing control data sheet⦁ Performing filling and finishing checks⦁ Ensuring Health Safety Hazards and Environmental Safety ProceduresPerforming Injection area test; Fill weight variation check, leak test, optical inspection of injectable product, pH check, washing cycle check, air cycle check (annually) Show less