Position Title: Executive – QC, Microbiology
Location information: Ankleshwar GIDC, Gujarat.
Requirements & Qualifications:
- M.sc (Microbiology / Biotechnology) / B. Pharm with 2-4 years of Experience as microbiologist in the similar industry
- GMP & GLP knowledge
- Good coordination & communication skills.
- Analytical ability
- Knowledge on LIMS & QMS
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:
Carry out Microbial analysis of raw material and finished products, Microbial Monitoring of Controlled Area, and maintain proper documentation as per GLP and current guidelines.
Sampling of Potable, Process and Purified Water System and it’s Microbial Analysis.
Perform Bacterial Endotoxin [LAL] Tests.
Trending of microbial results for MLT
- Good Laboratory Practice
Performing calibration & maintenance of lab. Equipment (viz., Balance, Incubator, Autoclave etc,. used in microbiology lab.) and assisting for the qualification of laboratory equipment.
Handling of culture, media, laboratory reagents & chemicals.
Participating in Investigation of out of specification results, retesting and review the analysis records.
Maintaining laboratory raw data related to microbiology testing activity.
- Validation
Perform Microbiology Analytical Method validation, cleaning validation as per the protocol.
- Other
Coordinating with production for EM & water sampling activities
Knowledge on HSE Requirements for QC laboratory.
Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations.
Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.
What makes this position unique?
- This position will provide good exposure to work in GMP/ GLP environment.
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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.
