Ribosome Research Centre Private Limited is a leading, Gujarat-based Contract Research Organization providing a wide range of non clinical research services aimed to deliver to a spectrum of industries like Pharmaceuticals, Herbals, Bulk drugs, Chemicals, Agro-chemicals, Medical devices, Food and cosmetics manufacturers. The research facility has employed state-of-the-art facility across its landscape spread over 100,000 sq ft in an 8 acre campus.
Post : Officer / Executive / Sr. Executive- Microbiology
Job Description
• Overall Management of Microbiology Laboratory and to ensure lab function is in compliance with GLP, cGMP and other Regulatory Requirements.
• Coordination with Quality Assurance & Production for compliance of inputs and products with respect to microbiological parameters.
• Handling of analysis of BET, Sterility & MLT with method validations.
• Investigations of failures in environment, water system & quality of product with respect to microbiological parameters.
• Responsible to investigate incident, deviation, complaints, OOS, OOT, recalls,batch failures, audit observations, related to GMP concern.
• Preparation of SOPs, STPs and Validation protocols related to microbiology department.
• Checking of all day to day microbiological records.
• Generation of protocol and execution of Method Validations and Other relevant Microbiological Validation.
• Coordination with Instrumentation, Maintenance, Vendors and Outside parties with respect to the procurement, servicing, qualifications and calibration of various equipment & system related to Microbiology.
• Review and approval of Environmental & Water quality trends and other batch releasing microbiological parameters (Bacterial Endotoxin, Particulate Matter, Sterility, Total aerobic counts and Microbial Limit tests of water & non-sterile product.
• Conducting Training program for the newcomers & updation of microbiological requirements for the existing Microbiologists & the manufacturing personnel.
• Validation support for DHS, autoclave, HVAC for manufacturing facilities and microbiology laboratory.
• Validation supports for Media fill studies.
• Assurance of consistent operation and performance all microbiological equipment, Instruments & System.
• To support regulatory affairs for microbiological aspects & document support for regulatory submissions & amendments.
• Microbiologist qualification
• To test all the samples of Sterility Testing, Microbiological Testing, Stability Samples, Environmental monitoring, Bacterial Endotoxins, water testing etc.
• To Prepare and update protocols, Specifications , Method of analysis as per SOP.
• To operate , Clean and Calibrate the instruments as per SOP
• To Implement & Ensure the latest SOPs, cGMP, cGLP etc.
Candidate Profile
- PhD or Master in pharmacology & Toxicology Or Life science.
- Minimum of 5 years’ experience in the pharmaceutical industry within Pre-Clinical sector.
Experience in regulatory preclinical development studies, including studies management in the fields of Toxicology or ADME.
- Good knowledge of the GLP
- Experience selecting and managing CRO relationships
- Project management experience
- Good team skills and ability to work in an interdisciplinary and international environment
- Excellent oral and written communication skills (English & French)
- Autonomous and rigorous.
Additional Information
Experience : MS/M.Sc(Science) in Biotechnology, Microbiology
Qualification : 2 to 8 yrs
Location : Kim,Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 15th June, 2021
Please submit your CV and cover letter in PDF format. Please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.
E-Mail : hrd@sdparc.com
Posted by
pratima
RIBOSOME RESEARCH CENTER PVT. LTD
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