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Job Ref. ID:  30349 
Job Title: Team Leader- Microbiology
Division: QUALITY CONTROL
Country: UNITED ARAB EMIRATES
Work Location: UAE (RAK head office)
Job Type: Quality Control - Microbiology Team Leader
Employment Type: Full Time Employment (Un-limited Contract)
Job Description:
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: • Should be able to supervise the Microbiological analysis of raw material, packing material, inprocess, finished product and stability samples. • 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. • Should be able to prepare and update the SOPs, Validation protocols, STMs related to Microbiology. • Should be involved in Media fill studies and validation of equipment like Autoclave, Tunnel/DHS, LAF/Biosafety cabinets, Incubators, etc. • Should have experience in Antibiotic assay and other microbiological validations like Disinfectant efficacy, Hold time studies. • Should have experience in handling cultures, culture suspension preparations, identification of isolates, preparation of isolate library. • Should be able to handle the team of Microbiologists and maintain the lab in compliance to requirements of cGMP, GLP and data integrity. • Should have Solid Technical knowledge on regulatory guidelines and Pharmacopoeias with strong implantation skill. • Should be able to perform GAP assessment and prepare risk mitigation plans. • Should review and ensure that Microbiological analysis records are complete on day-to-day basis. • Should be able to train and qualify the microbiologists for different microbiological analysis. • Should participate in Internal and Regulatory audits and assure microbiology lab readiness for the GMP audits, at all the times • Responsible for effectively handling change controls, deviations, CAPA implementation and monitoring its effectiveness in Microbiology • High on communication and collaboration, having an ability to manage multiple stakeholders at a time • Actively participate in continuous improvement initiatives. • Keeps up to date with all relevant regulations (GXP, GMP, ICH, WHO, FDA, ISO etc.); in compliance with regulations. • Establish SOP's based on QMS, and revise them as necessary. Manage SOP's based on related procedures • Monitor monthly performance and function KPIs to ensure the organization objectives in the areas of cost, efficiency, and compliance are met. • Responsible for preparation, execution and aftercare of any such Improvement Projects within the assigned work area. Core Competency • In terms of Competency you are highly result oriented with strong sense of accountability & ownership, • Excellent communication, interpersonal and presentation skill. • 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 • Method validations of Sterility, Bacterial endotoxin testing, Expert in handling OOS results in Microbiological analysis, Water and Environmental monitoring. • 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 • Strong Manpower handling skills and having effective team communication and motivational skills. • Capable of suggesting ideas in a structured manner and having good Command on English language. • You are a team player with a proactive and collaborative approach and enthusiastically manage stakeholders in good spirit.
 Qualifications: 
   - Education 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. Extensive Knowledge in cGMP ,GDP ,PV and regulatory guidelines. • Previous experience in a similar role and with experience in a Pharmaceutical/ Healthcare Industry is preferred • Must be experienced in managing complex and sensitive operational challenges.
   - Training:
Key Competencies: • Knowledgeable with SOP writing, GMP compliance. • Strong IT skills, inter personal skills and technical knowledge.  
Technical Competencies:  
 

 
 

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