Position Title: Sr. Executive – QC, Microbiology
Requirements & Qualifications:
- M.Sc. (Microbiology / Biotechnology) / B. Pharm with total 6-9 years of Experience in the microbiology laboratory of Pharmaceuticals & API & out of the total experience 3-4 years of Experience as a team leader
- GMP & GLP knowledge
- Knowledge of various applicable guidelines viz., USFDA, EU, Indian FDA, WHO, ICH
- Good coordination & communication skills.
- Conduct training to subordinate
- Knowledge of budgetary / procurement aspects
- Analytical Ability, Team building, troubleshooting
- Day to day planning of laboratory activities
Job overview:
- Implement quality control activities at Zentiva - Ankleshwar adhering to regulatory / global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet with customers’ requirements.
Responsibilities:
- Analysis:
Advanced knowledge, specifically on solid oral dosages & API’s;
- Microbial analysis of raw material and finished products, Microbial Monitoring of Controlled Area, Water samples and maintain proper documentation as per GLP and current guidelines.
- Sampling of Potable, Process and Purified Water as well as understanding of Water System
- Bacterial Endotoxin [LAL] Tests.
- Good Laboratory Practice
Knowledge of calibration & maintenance of lab. Equipment (viz., Balance, Incubator, Autoclave etc,. used in microbiology lab.) and performing qualification of laboratory equipment.
Preparing Microbiology laboratory documents, viz., SOPs, recording Formats, Analytical Test Record, Protocol & Report for Method validation & Equipment qualification
Handling of culture, media, laboratory reagents & chemicals.
Investigation of Laboratory incidents, out-of-specification / out-of-trend results
Review of laboratory raw data related to microbiology testing activity & Trending of data
Knowledge of QMS & e-tools, instrument software, and LIMS.
- Validation
Advance knowledge on Microbiology Analytical Method validation, cleaning validation, and computerized systems
- Others
Knowledge on HSE Requirements for QC laboratory.
Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations.
Handling of projects as per the instruction of the department. Head to meet with the organizational objectives and priorities.
Identifying and planning requirements for laboratory consumables and monitoring the stock of chemicals, spares & glassware.
What makes this position unique?
- This position will provide good exposure to work in GMP/ GLP environment.
Location information: Ankleshwar, Gujarat India
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What We Do
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 almost 5,000 unique talents bonded together by our mission to deliver high-quality and affordable medicines to people who depend on them every day. 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.
