Quality Operations Specialist

Role Quality Operations Specialist MANDATORY REQUIREMENTSGraduated post-graduate in Pharmacy Medicine or Chemistry Biotechnology 5 to 8 years minimum experience in Quality or Regulatory Affairs Experience obtained in pharmaceutical manufacturing sites 3 years Knowledge of stability regulations and its application to the industry Skilled in the usage of IT tools for example Quality Forward Share DrugTrack eDMS SAP English speaker Good organizational skills stress resistance and flexibility Good Team player and good in decision-making Interpretation Analytical data Experience in the pharmaceutical biotech industry with a good level of GxP know-how is a strong plus Reactivity autonomy with a sense of urgency and priorities Open-mindedness and team spirit Position Location Ankleshwar Zentiva Pvt Ltd Gujarat India ROLE SPECIFICATIONS Role Quality Operations Specialist Department Scientific Affairs Reports to Quality Compliance Manager Company Zentiva Italia S r l PURPOSE OF THE ROLE Support the Quality Assurance and Compliance function of Zentiva Italia S r l in order to ensure compliance with Zentiva Italia S r l applicable requirements and Corporate Zentiva guidelines The role will be focused in leading a periodic review of products commercialized in Italy under the Zentiva Italia S r l authorization MAIN RESPONSIBILITIESReporting to Zentiva Italy Quality Compliance Manager the Quality Operations Specialist will take lead responsibility for Product Quality Reviews PQR review completion for the cases in which Zentiva Italia S r l is marketing authorization holder MAH Responsible to meet the established schedule in completing the reviews of PQRs For each evaluated PQR the Quality Operations Specialist will ensure that the traceability of the evaluation report is always available document crated approved signed and properly archived according to Zentiva Italy procedures Responsible for flagging escalating to the Zentiva Italy Quality Compliance Manager any delays on time Prepares trends analysis and KPI on PQR review process Responsible for ensuring the maintenance of a up to date document for tracking of PQRs review operations and will support Zentiva Italy Quality Compliance Manager in the preparation of periodic reporting of the PQRs review The tracking document shall permit to Zentiva Italy to identify PQRs evaluated as to be improved or which are not meeting the requested quality standards Responsible for calculating PQRs review KPIs on monthly basis Responsible for the extraction and data compilation of analytical manufacturing including deviations complaints and change requests from appropriate IT tools Quality Forward Share DrugTrack eDMS and regulatory data HA commitments variations Responsible for collecting stability data and reports for product-related evaluations e g compliance investigations divestitures product transfers validation etc Responsible for scheduling meetings with the transversal functions in case clarifications are needed or to determine and assign follow-up action items if required Support the PQR review related deviation investigations CAPA plan follow-up on PQR related issues with transversal functions and CMO if required communicate with CMOs as required Participate to inspections Where requested support the Zentiva Italy Quality Compliance Manager in the review of Qualification status of the Zentiva Italy third parties such as suppliers Risk assessments update Quality Agreements update and Zentiva entities Quality Agreement update Where requested support the Zentiva Italy Quality Compliance Manager in the management of incoming batch controls including quarantine arrivals and related scraps communication to the Italian Health authority OTHER RESPONSIBILITIES QUALITY Comply with the principles of cGxPs and Zentiva s Quality Standards in carrying out the activities of competence and regularly participate in the related training HSE Comply with the principles communicated within the framework of the Zentiva ESMS Policy specified in the Company s internal regulations for the purpose of compliance with Occupational Health and Safety regulations and the Environment and Safety Management System VIGILANCE Report adverse events and any other safety information related to ZENTIVA medicines medical devices cosmetics and dietary supplements online in the manner provided for in internal procedures COMPLIANCE Observe the Company s rules and policies Fully adhere to the principles set out in the Code of Ethics SUSTAINABILITY Adhere to the ESG principles detailed as part of Zentiva s Sustainability Strategy which is divided into 3 pillars People Partners Planet