ResponsibilitiesPerforming and organizing timely analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals. Performing and organizing analysis of market complaints, Stability, process validation, Cleaning Validation samples of Pharmaceuticals. Good Laboratory Practice Performing and organizing calibration / maintenance of lab. Equipment and assisting for the qualification of laboratory equipment. Reviewing pharmacopeias for specification preparation. Preparing SOPs, Formats, Specification, Analytical Test Record and other documents. Managing reference standards, working standards, Laboratory chemicals & reagents. Managing instrument laboratory with reference to spares, maintenance etc. Managing Control Samples and related record. Approval / Rejection of Raw Materials, Packaging materials, in process materials, Bulk Finished products and bulk medical device. Investigating out of specification results, retesting and review the analysis records. Maintaining & reviewing laboratory raw data and log book related to testing activity. Responsible for reviewing the chromatographic data.Qualification & ExpeirencePost Graduate in Science (Organic or Analytical Chemistry) or B.Pharm/M.Pharm 5-7 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 substances Assure compliance with local regulations in Switzerland, international GDP / GMP requirements and the company Write SOPs and relevant documents, manage them in eDMS (electronic Document Management System) and support in implementation by training employees QA GMP, systems: GMP and process trainings, personal file maintenance Providing support to ensure inspection readiness and participation on internal audits and HA inspections QA POs executions in Fiori Product Quality Management Preparation of Market release of purchased or repacked products for Swiss Market: Str. 2 ZENTIVA JOB DESCRIPTIONEnsure completeness of batch documentation for batch release and request relevant documents form the suppliers or internal stakeholders, if necessary

ResponsibilitiesReview 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. Archival & Records Retention Manage the archival room and document storage systems for controlled and historical GMP documents. Ensure secure storage, easy retrieval, retention compliance, and protection against unauthorized access or damage. Support audits and inspections by ensuring availability of archived records.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

ResponsibilitiesDispatch and line clearance activities. Review of executed BMR, BECR, and analytical raw data. Preparation of process validation protocols and monitoring of process validation activities. Preparation and revision of SOPs. Preparation of Annual Product Reviews (APR). Handling of cleaning validation activities. Initiation and coordination of deviations and change controls whenever required.

ResponsibilitiesTo give line & area clearance in dispensing, manufacturing and packing activities. To carry out in-process checks and challenge tests as per the frequency and the procedure defined in respective Batch Production Records and SOPs. To perform the sampling of in-process, semi-finished. To ensure that the manufacturing and packing operations are carried out as per the instructions given in the Batch Production Record. To perform the activities in SAP like Process order approval for BPR printing, Reprinting of additional page. To perform and check the calibration of the IPQA apparatus. To carry any other job allotted by shift in-charge Execution of validation and qualification activities as per defined protocol. To ensure compliance, correctness of manufacturing area and to check standard procedures are followed during manufacturing

Responsibilities   MI Operations Leadership – U.S. Focus and also Global Flexibility -End?to?end U.S. MI operations run per MI Control Docs and GMI SOPs; compliant, balanced, timely responses; documented separation of promotional/non?promotional; flexible support to other regions as assigned. Content Governance & Change Control U.S. SRDs/FAQs and digital MI content aligned to current U.S. PI and evidence standards; controlled updates for label/safety changes; complete audit trails in repository; periodic content quality reviews passed. Inquiry Handling Oversight, Documentation & Privacy Unsolicited, non?promotional fulfillment; accurate verbatim capture; documentation completeness; adherence to privacy expectations (incl. HIPAA?aligned handling where applicable); periodic QC shows ?95% documentation accuracy. Assist GMI Head/ Designee in miscellaneous activities and projects as assigned Effective support for strategic and operational initiatives; tasks completed within agreed timelines PV & Product Quality Integration Reliable intake and on?time routing of AEs/special situations and PQCs to PV/QA per SOPs and regulatory timelines; reconciliationsQualification & ExperienceAdvanced degree preferred: PharmD / PhD / MPharm (or MSc in Life Sciences with substantial MI leadership experience). Additional certifications in GxP, Medical Affairs/ MI (e.g., MAPS/MILE/phactMI), or quality systems are an advantage. Experience: 8 to 12 years total industry experience in Medical Information, with 3-5 years leading US MI/ Global operations (content governance, inquiry handling oversight, vendor management, SLAs/KPIs, PV/PQC handoffs)

ResponsibilitiesServe as the primary administrative point of contact for a group of 4 senior leaders, ensuring smooth day-to-day support. Manage requests with a high level of confidentiality, professionalism, and urgency. Anticipate needs and proactively resolve issues before they escalate.  International Travel Planning & Logistics Plan and coordinate end-to-end international travel including flights, hotels, ground transportation, and itineraries. Build multi-leg, multi-country travel plans that optimize time, cost, and leader preferences. Prepare detailed travel itineraries, briefing packs, and contingency plans for disruptions (e.g., delays, cancellations). Partner with travel agencies and vendors to ensure service quality, accuracy, and compliance with company policy.  Visa, Immigration & Documentation SupportCoordinate visa applications and travel documentation for leaders traveling internationally (e.g., UK, Schengen, UAE, and other destinations as needed). Liaise with immigration vendors/consulates, internal mobility teams, and travelers to gather documents and track submissions. Maintain trackers for visa status, passport validity, and travel documentation requirements. Ensure timely renewals and compliance with entry requirements. Travel Insurance & Risk/Compliance CoordinationQualification & ExpeirneceBachelor’s degree or equivalent practical experience. 3–7 years of experience in an Administrative Assistant, Executive Assistant, or similar role supporting senior stakeholders.

ResponsibilitiesTo perform Media Preparation, Autoclave Operation related all activity, Sterilization all activity Fumigation Related activity etc. Environment monitoring. Water testing. LBPC testing. Operation and calibration of pH meter. MLT Testing. Sterility testing. Cleaning validation. EM & Water Trend Preparation. Environment monitoring excursion investigation (MDD & MOT). Having knowledge on Micro related guidelines. Good aseptic practice knowledge.

ResponsibilitiesManaging in-process QA shopfloor team as a shift in-charge Well versed in the In-process Quality Assurance activities which includes review of BMR, BPR, Logbooks. Tracking of in-process samples and ensuring timely release of areas for manufacturing and packing. Review of Audit trails/ events and Alarms. Transactions in software such as SAP, DMS, QMS, e-Logs and other applicable software. Line clearance and inspect shop floor activities. Performing Assay calculation, in-process checks during manufacturing activities as per BMR. Reconciliation of batch at various stages of manufacturing and packing of the batch. To perform swab/ rinse sampling of manufacturing and packing equipment and submit samples to QC for testing. Monitoring of reject handling on shopfloor. Identification of opportunity of process and practice improvement on shop floor. Ensure all time compliance at manufacturing, packing and warehouse shop floor. Immediate reporting of observed non-compliance to IPQA In-charge/ QA Head.Qualification & ExpeirenceB. Pharm/ M. Pharm/ M.Sc. With relevant experience in pharma. Must have knowledge of working on the shop floor as an in-process quality assurance. Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA Exposure to specific dosage forms like OSD, Liquid Orals, Nasal (optional) Effective communication, Team coordination and work in collaboration within compliance

ResponsibilitiesChecking and verification of Dispensing of materials and label generations as per approved procedures including Cross check of material identity and quantity Supervise dispensing activity to ensure compliance with Good Dispensing Practices and cross-contamination prevention measures. Coordinate with production and QA for line clearance and material reconciliation. Ensure all transactions are documented in e-logs and other software systems Ensure all transactions are done under controlled environment conditions including monitoring of daily environment records Ensure the cleaning of the area along with preparation of sanitation solutions and maintain proper records. Conduct calibration/daily verification of Weighing balances and other equipment as per SOP and schedule. Perform the dispensing of solvent materials. Perform QMS activity related to warehouse.Qualification & ExpeirenceQualification: -BSC /B. Pharm /D. Pharm or equivalent Experience of NLT 2 years Should have exposure to handling of SAP systems.