Job Title- Executive Quality Assurance (Pharmaceuticals)
Educational requirement
B.Pharm or M.Pharm with 1-5 years of experience.
Quality Management/Continuous Improvement
Line Clearance and shop floor compliance
Carry out in-process checks and calibration of IPQC instruments.
Handle e tools i.e. SAP Hana, LIMS, eDMS, Track Wise system.
Assisting inComplaint Investigation systemat site
Assisting in Qualification and validation system, change control system,deviations
Preparing& reviewthe Annual ProductQualityReview
Review of Batch Manufacturing & Packing Records
Coordination of cGMP Training activity
Compliance
Ensure adherence to company Quality Standards, LocalEU,FDA,MHRA regulations, by
Understanding the requirements
Performing the Gap analysis to find out the gaps in existing system
Preparing a compliance plan for closure of gaps
Execution of compliance plans
Review of completion forcompliance activity
Validations & Qualifications
Ensure validated status of all equipment’s, manufacturing processes, and cleaning processes
Review of protocols for qualification and validation of facility/ equipment / product / process
Review of validation reports after execution of validation of facility /equipment / product / process
Documentation Control:
Preparationand Review ofSOPs
Controlled distribution and archival of documents &record
Control of master documents
Assuring quality of products by :
Ensuring SOP compliance
Review of Batch Manufacturing & Packing Records
Ensuring implementation of Corrective actions/Preventive actions proposed in Deviationsand Customer complaints
Ensuring the effectiveness review of the implemented CAPA
cGMP Training
Topreparetraining modules and organize training in GMP
Execute the training program in coordination with all concerned departments
Other:
Reviewof maintenance and calibration program
Zentiva is a Pan-European Platform developing, manufacturing and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We offer solutions in key therapeutical areas like Cardiology & Circulation, Diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe.
We are a team of more than 5,000 unique talents bonded together by our purpose to provide health and wellbeing for all generations. We want Zentiva to be a great place to work, where everyone feels welcomed and appreciated and can be their true selves contributing to the best of their ability.
Data protection: It’s not just a checkbox – it’s our commitment! Please visit our Privacy Notice https://www.zentiva.com/gdpr/privacy-notice
