ResponsibilitiesIssuance, archival and retrieval of documents. Issuance of Control coples to respective dept. Destruction of the GMP documents once the retention term has passed and controlled coples of the obsolete GMP documents. Tracking of all QA documents. 5. Maintaining backup of QA softcoples. Maintaining SOP/s with proper indexing. Preparation and review of SOPs Management of QA Stationary (Controlled Coples and logbooks) Dispatch and line clearance activity. Review of BMR/BECR Perform Qualification for new Equipments/Existing Equipments Ensure & Co-ordination of area validations. Reviewing of calibration /PM Schedules. Preparation of VMP &validation Documents Handling of Vendor Qualification Activities. Any other work assigned by HOD/Second line.

ResponsibilitiesPreparation of protocol for validation/qualification pertaining to Process, Cleaning, Equipment and area/HVAC Execution of validation/qualification activities Coordination with different departments for performing validation/qualification activities Compilation of data and report preparation Maintaining documents as per Document control policy Lessoning with FDA for manufacturing licenses and certificates.

ResponsibilitiesDesigns, prepares, and reviews stability protocols for R&D QA pre-approval. Evaluates analytical methods to determine suitable quantities of product for stability studies based on the corresponding testing plan. Reviews and evaluates stability data for the ongoing stability studies to ensure that significant trends that warrant attention are evaluated. Notify Manager of any concerning trends detected. Prepares, reviews, and publishes Stability Summary Reports, Executive reports, Shelf-life extension reports, Statistical evaluation reports, etc. within compliance time frame. Prepares and provides stability summary reports, including trend analysis and product evaluations for internal or external customers. Performs review of stability summary data provided by third party affiliates (e.g., contract laboratories) for completeness and compliance. Provides day to day technical support, direction, and guidance to the R&D Stability team members, including problem solving and troubleshooting of stability program related issues, and suggests remedial and corrective actions, when required. Acts as an area SME on TrackWise - Deviation and CAPA management system. Proficient in creating and verifying stability protocols in LIMS, and initiating stability studies. Prepares and oversees the execution of the monthly stability pull schedule, and assists with the preparation of different stability status reports, including the monthly reports. Involved in the creation and management of departmental change controls within the QMS Trackwise system. Liaises with LIMS Operations, Formulations Development and colleagues in Analytical R&D to ensure that all information required for stability protocol is complete. Provides information regarding the R&D stability studies to Formulation Development, Global Regulatory Affairs and other internal/external customers. Performs specification updates to all active stability studies within Labware LIMS when a change control for stability test profile is completed. Logs all Environmentally Control Chamber alarms from Building Systems and performs quarterly alarms reconciliation. Works with Manger, R&D Stability to improve departmental processes and SOP’s. Provides weekly status updates to the Manger, R&D Stability. Shares knowledge with team members and across R&D. Provides cross training and support to new team members. Monitors training progress and ensures all training gaps are completed within MyHR for Documents, GMP, Safety, Technical and Software courses. Works as a member of the team to achieve all desired quality/compliance outcomes. Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. Demonstrates Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensures personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned, including back-up for coordinator role.Qualification & ExperienceA graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university. Knowledge, Skills and Abilities Strong working and theoretical knowledge of ICH Guidelines as it pertains to NPD Regulatory submissions. Thorough understanding of GMP and GLP guidelines and related SOPs and their application in a laboratory setting.6+ year experience in pharmaceutical industry, preferably including experience in project management and coordination of work assignments.

ResponsibilitiesResponsible for tech-transfer of injectable and ophthalmic formulations from R&D to commercial scale Gap analysis - To evaluate the product feasibility, technology feasibility at manufacturing site along with gap analysis with available technology for site readiness Documentation – Onsite documentation, and timely execution of scaleup, exhibit and validation batches Risk assessment – To carry out the risk assessment to identify the impact of critical process parameters and critical material attributes To design and review the sampling plan for scaleup, process optimization and submission batches To study and verify the parameters established during development are still with in the determined design space in scaleup and exhibit batches To coordinate with other departments at plant in completing scaleup and exhibit batch related activities In coordination with CMO and PM, ensure the availability of raw materials, packaging materials, filters, tubings etc. required for scale-up, exhibit and commercial batches before initiation of execution Compile the batch orsevations and prepare the report of scale-up, EB and commercial/PV batches To ensure smooth technology transfer of products developed at Apotex to CMO Technical support to formulation development team Involve in formulation development activities and assist in development of scaleable manufacturing process Review and compilation of the developmental plant scale batches data and stability results Coordination with different cross-functional teams like AD, procurement, QA, packing, regulatory affairs, project management for smooth execution of scale-up batches Coordination with external labs for successful completion and receipt of studies data performed for plant scale batches Review of MFR, BMR, BPR, stability protocols, study protocols and reports, Executed BMR, BPR, Issuance, maintenance, writing, review of raw data, completeness check and archival of laboratory notebook Coordination with vendor and internal service engineer for installation, calibration, maintenance and trouble shooting Report to next level manager regarding day to day activities. Preparation of SOPs and ensure compliance as per SOP Take up any other work as allottedQualification & ExperienceD /M Pharma in Pharmaceutics/B.Pharma. Knowledge, Skills and Abilities Must have experience in development and tech-transfer of injectable and ophthalmic and complex drug products Effective command over verbal and written communication with good interpersonnel skills. Engage with CMO partners and support the group submission plans Proficient in MS office and advanced software tools. Having well versed knowledge on regulatory guidelines Able to priortise the task, best in effective planning of work activities to meet the timelines. Experience Minimum 6 to 10+ years of experience in Injectable and Ophthalmic dosage forms in area of Development, Manufacturing and technology transfer expertise for CMO.

ResponsibilitiesAnalysis of packing material, raw material samples as per method of analysis by adhering to the Regulatory Procedures. Sampling and analysis of water as per the procedures defineded. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. Any other Responsibilities / Duties assigned by the Head of the Department / Designee as and when required. Performs all work in support of our Corporate values of perseverance, passion, collaboration and courage. Performs all work in accordance with all established regulatory and compliance and safety requirements. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned.Qualification & ExperineceMinimum Msc/Bpharm or any equivalent degree. Knowledge, Skills Abilities Effective command over verbal and written communication with good interpersonal skills Command on Microsoft-office (Word, Excel) Able to perform all the allocated tasks Well expertised in cGDP and cGLP. Best in effective planning of work activites to meet the time lines Experience: Minimum 3 to 6 years of experience in GMP regulated Pharmaceutical Industry

ResponsibilitiesPerforming timely sampling and analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals. Performing analysis of market complaints, Stability, process validation samples, Cleaning Validation of Pharmaceuticals. Good Laboratory Practice Performing calibration & maintenance of lab. Equipment and assisting for the qualification of laboratory equipment. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining record. Participating in Investigation of out of specification results, performing retesting. Maintaining laboratory raw data related to testing activity.Qualification & ExperienceEducation / Experience: Post Graduate in Science (Organic or Analytical Chemistry) 1 - 5 years in chemical & instrumental testing laboratory with exposure to GMP, GLP.

ResponsibilitiesQuality system management Implement and maintain a local quality system applying primarily to SwissMedic-regulated activities related to the import and distribution of products and controlled substancesAssure compliance with local regulations in Switzerland, international GDP / GMP requirements and the companyWrite SOPs and relevant documents, manage them in eDMS (electronic Document Management System) and support in implementation by training employeesQA GMP, systems: GMP and process trainings, personal file maintenanceProviding support to ensure inspection readiness and participation on internal audits and HA inspectionsQA POs executions in FioriProduct Quality ManagementPreparation of Market release of purchased or repacked products for Swiss Market:

ResponsibilitiesReview of Master Documents Review and maintain Master Batch Manufacturing Records and Master Batch Packing Records to ensure accuracy, regulatory compliance, and alignment with approved specifications and process related changes. Coordinate with Production, QC, and Regulatory Affairs for timely updates and approvals. Annual Product Quality Review (APQR) Prepare, compile, and review Annual Product Quality Reviews (APQRs) in line with regulatory expectations. Support identification of improvement opportunities and follow-up of CAPAs arising from APQR findings. cGMP Training Coordination Coordinate and monitor cGMP and quality-related training programs for site personnel. Maintain trainingschedules, records, and effectiveness assessments.Qualification & ExperienceBachelor’s or master’s degree in pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline. Experience 1–5 years of relevant experience in Pharma Quality Assurance / Documentation

ResponsibilitiesPeriodic review and updates to quality agreements to ensure alignment to Amgen expectations and to address needs depending on material type. Documentation review and approval including: supplier manufacturing records, investigation reports, Amgen quality records, and validation records (process & analytical) . Evaluation and documentation of raw materials and devices for changes to incoming inspection profiles Oversight and completion of supplier assessments and documentation to support product complaints. Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships. Review and approval of change control records for supplier changes. Management of supplier audit records, ensuring on time completion and CAPA closeout activities are documented with appropriate closeout evidence. Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. Take part in operational and quality improvement initiatives, programs, and projects. Develop solutions that are thorough, practical, and consistent with functional objectives This role may require working in shifts or extended hours within the same shift to support global time zones.Qualification & ExperienceMaster’s degree with 10 years of experience in manufacturing and quality management systems or a related field OR Bachelor’s degree with 12 to 13 years of experience in quality management systems or a related field 

ResponsibilitiesResponsible for managing QA documentation, ensuring GMP compliance, and supporting quality systems through effective handling of SOPs, BMR/BECR review, validation and qualification activities. Oversees document control, vendor qualification, calibration and maintenance coordination, and ensures timely closure of deviations, change controls, and CAPAs while maintaining data integrity and audit readiness across all QA operations. Issuance, archival and retrieval of documents. Issuance of Control coples to respective dept. Destruction of the GMP documents once the retention term has passed and controlled coples of the obsolete GMP documents. Tracking of all QA documents. 5. Maintaining backup of QA softcoples. Maintaining SOP/s with proper indexing. Preparation and review of SOPs Management of QA Stationary (Controlled Coples and logbooks) Dispatch and line clearance activity.