Role: Quality Operations Specialist
MANDATORY REQUIREMENTS
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Graduated / post-graduate in Pharmacy/Medicine or Chemistry/Biotechnology
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5 to 8 years minimum experience in Quality or Regulatory Affairs
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Experience obtained in pharmaceutical manufacturing sites (+3 years).
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Knowledge of stability regulations and its application to the industry
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Skilled in the usage of IT tools (for example: Quality Forward, Share/DrugTrack, eDMS), SAP.
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English speaker
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Good organizational skills, stress resistance, and flexibility
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Good Team player and good in decision-making
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Interpretation/Analytical data.
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Experience in the pharmaceutical/biotech industry with a good level of GxP know-how is a strong plus.
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Reactivity, autonomy with a sense of urgency and priorities.
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Open-mindedness and team spirit.
Position Location:
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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 RESPONSIBILITIES
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Reporting 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).
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Responsible to meet the established schedule in completing the reviews of PQRs.
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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.
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Responsible for flagging /escalating to the Zentiva Italy Quality & Compliance Manager any delays on time.
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Prepares trends analysis and KPI on PQR review process.
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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.
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Responsible for calculating PQRs review KPIs on monthly basis.
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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).
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Responsible for collecting stability data and reports for product-related evaluations. (e.g. compliance investigations, divestitures, product transfers, validation. etc.).
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Responsible for scheduling meetings with the transversal functions in case clarifications are needed or to determine and assign follow-up action items, if required.
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Support the PQR review related deviation investigations.
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CAPA plan follow-up on PQR related issues with transversal functions and CMO if required, communicate with CMOs, as required.
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Participate to inspections.
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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).
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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.
