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Purpose: The Team Leader-Microbiology is expected to ensure the adherence with cGMP principles, Good laboratory practices and to maintain them in an effective manner. Team leader will be responsible to oversee all the microbiology analysis and monitoring activities. Will be the key to investigate the out of specification results and close out. Will be able to perform risk assessments related to Microbiological activities and sterile operations. Should be a subject matter expert in all Microbiological analysis and validations like Sterility, Bacterial endotoxin test, Microbial enumeration test, test for specified microorganisms. Moreover, he/she will be responsible to face external quality audits regulatory/customer audits hosting and audit management.
Key responsibilities & Accountability: \xe2\x80\xa2 Should be able to supervise the Microbiological analysis of raw material, packing material, inprocess, finished product and stability samples. \xe2\x80\xa2 Should be an expert on Testing of sterile products (like Sterility test & Bacterial endotoxin test), Testing of non-sterile products, Environmental monitoring and Water sampling & analysis. \xe2\x80\xa2 Should be able to prepare and update the SOPs, Validation protocols, STMs related to Microbiology. \xe2\x80\xa2 Should be involved in Media fill studies and validation of equipment like Autoclave, Tunnel/DHS, LAF/Biosafety cabinets, Incubators, etc. \xe2\x80\xa2 Should have experience in Antibiotic assay and other microbiological validations like Disinfectant efficacy, Hold time studies. \xe2\x80\xa2 Should have experience in handling cultures, culture suspension preparations, identification of isolates, preparation of isolate library. \xe2\x80\xa2 Should be able to handle the team of Microbiologists and maintain the lab in compliance to requirements of cGMP, GLP and data integrity. \xe2\x80\xa2 Should have Solid Technical knowledge on regulatory guidelines and Pharmacopoeias with strong implantation skill. \xe2\x80\xa2 Should be able to perform GAP assessment and prepare risk mitigation plans. \xe2\x80\xa2 Should review and ensure that Microbiological analysis records are complete on day-to-day basis. \xe2\x80\xa2 Should be able to train and qualify the microbiologists for different microbiological analysis. \xe2\x80\xa2 Should participate in Internal and Regulatory audits and assure microbiology lab readiness for the GMP audits, at all the times \xe2\x80\xa2 Responsible for effectively handling change controls, deviations, CAPA implementation and monitoring its effectiveness in Microbiology \xe2\x80\xa2 High on communication and collaboration, having an ability to manage multiple stakeholders at a time \xe2\x80\xa2 Actively participate in continuous improvement initiatives. \xe2\x80\xa2 Keeps up to date with all relevant regulations (GXP, GMP, ICH, WHO, FDA, ISO etc.); in compliance with regulations. \xe2\x80\xa2 Establish SOP\'s based on QMS, and revise them as necessary. Manage SOP\'s based on related procedures \xe2\x80\xa2 Monitor monthly performance and function KPIs to ensure the organization objectives in the areas of cost, efficiency, and compliance are met. \xe2\x80\xa2 Responsible for preparation, execution and aftercare of any such Improvement Projects within the assigned work area.
Qualifications:
- Education Bachelor\'s or Master\'s degree in Microbiology/related Life sciences
- Experience: Experience of minimum 12-14 years in Pharmaceutical Industry preferably in Sterile formulations, with 5+ years as Assistant Manager and above in Pharmaceutical Microbiology from companies having GMP approval from highly regulated authorities like USFDA/MHRA/EU/TGA. \xe2\x80\xa2 Extensive Knowledge in cGMP ,GDP ,PV and regulatory guidelines. \xe2\x80\xa2 Previous experience in a similar role and with experience in a Pharmaceutical/ Healthcare Industry is preferred \xe2\x80\xa2 Must be experienced in managing complex and sensitive operational challenges. \xe2\x80\xa2 Knowledgeable with SOP writing, GMP compliance. \xe2\x80\xa2 Strong IT skills, inter personal skills and technical knowledge.
- Training:
Key Competencies: \xe2\x80\xa2 In terms of Competency you are highly result oriented with strong sense of accountability & ownership, \xe2\x80\xa2 Excellent communication, interpersonal and presentation skill. \xe2\x80\xa2 Technical Competencies: In-depth knowledge of the industry\'s standards and regulations guidelines excellent knowledge of reporting procedures and record keeping, must have experience in handling Regulatory Authorities audits and questions and accordingly set up the action plan \xe2\x80\xa2 Method validations of Sterility, Bacterial endotoxin testing, Expert in handling OOS results in Microbiological analysis, Water and Environmental monitoring. \xe2\x80\xa2 Having an Analytical mind with ability to think diversely and understand the big picture, Methodical and diligent with outstanding planning abilities an analytical mind able to "see" the complexities of procedures and regulations \xe2\x80\xa2 Strong Manpower handling skills and having effective team communication and motivational skills. \xe2\x80\xa2 Capable of suggesting ideas in a structured manner and having good Command on English language. \xe2\x80\xa2 You are a team player with a proactive and collaborative approach and enthusiastically manage stakeholders in good spirit.
Technical Competencies:

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