Role: Manager- Quality Operations
MANDATORY REQUIREMENTS
Graduated / post-graduate in Pharmacy/Medicine or Chemistry/Biotechnology
10 to 14 years minimum experience in Quality or Regulatory Affairs
Experience obtained in pharmaceutical manufacturing sites (+8 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 positive in decision-making
Interpretation/Analytical data.
Experience in the pharmaceutical/biotech industry with a valuable level of GxP know-how is a solid 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
Department: Scientific Affairs
Reports to: Quality & Compliance Manager
Company: Zentiva Quality Operations

PURPOSE OF THE ROLE




Support the Quality Assurance and Compliance function of Zentiva Quality Operations . in order to ensure compliance with Zentiva Quality Operations applicable requirements and Corporate Zentiva guidelines.
The role will be focused in leading a periodic review of products commercialized under the Zentiva Quality Operations authorization.

MAIN RESPONSIBILITIES
Reporting to Zentiva Quality Operations & Compliance Manager, the Quality Operations Specialist will take lead responsibility for Product Quality Reviews (PQR) review completion for the cases in which Zentiva Quality Operations 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 Quality Operations

📌 Manager Quality Operations Ankleshwar
🏢 Zentiva Group
📍 Ankleshwar