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Post : QC Microbiologist
Job Description:
Preparation and review of URS, DQ, IQ, OQ and PQ documents required for microbiology laboratory instruments as per the requirement. To execute instruments and equipment’s operation, calibration and qualification in microbiology lab. Handling of samples management and adherence to the schedules. Sampling and analysis of water samples, raw materials, packing materials, in-process samples, finished products and miscellaneous samples for Bacterial Endotoxin Test (BET), sterility, bioburden, specified organism, microbial limit test, Biological indicators etc. Environmental monitoring of Isolators, Laminar Air Flow Units, Biological safety cabinets, Pass boxes and clean rooms. Preparation, sterilization, Growth Promotion Test and decontamination of microbiological media. Handling and identification of microbial isolates and maintenance of microbial cultures. To execute the miscellaneous validations. To support in preparation of documents viz. Specifications, Standard Testing Procedures, Standard Operating Procedures, Method Validation Protocols, Miscellaneous validation protocols and reports etc. To participate in Method transfer and method validation for analytical methods as per transfer strategy. Preparation of microbiological trends as per requirement. Responsible for Initial Laboratory Investigation (OOS or OOT), Deviations, CAPAs and Change Control Management related to Microbiology Lab. Ensures clean and hygienic environment in Microbiology laboratory. To identify, correct and promptly report unsafe conditions, behaviours, or potentially hazardous situations Performs other responsibilities delegated by Department Head as per requirement.
Knowledge, Skills & Competencies / Language
• Knowledge of GMPs related to Microbiology lab in both domestic and international regulatory environments is required.
• Knowledge of Microbiological testing, qualification and handling of analytical instrument and equipment related to Microbiology is required.
• Good organizational, interpersonal and communication skills are essential.
• Working knowledge on computer, Microsoft word, excel and power point
• LEAD competencies:
• Act for Change: Embrace change and innovation and initiate new and improved ways of working.
• Cooperate Transversely: Collaborate effectively with peers, stakeholders and partners across the organization to positively impact business results.
• Develop People: Take responsibility for developing one's self in anticipation of future business needs.
• Excellent verbal and written communication skills in English is required.
Candidate Profile
• A minimum of Bachelor or Master’s Degree in Science or Pharmacy is required. Specialization in Microbiology is a plus.
• A minimum of 3 plus years of experience in Pharmaceuticals is required.
• Working experience in an Injectable Pharmaceutical Microbiology lab is an advantageous.
Additional Information
Experience : 3 years
Qualification : B.Pharm, M.Pharm, M.Sc, B.Sc
Location : Toopran Mandal, Andhra Pradesh
Industry Type : Pharma
End Date : 10th April, 2019
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