Job Description :
Purpose : The Senior Specialist - Microbiology is responsible to ensure the adherence with cGMP principles, Good laboratory practices and to maintain them in an effective manner.
Responsible to perform method validation for Sterility, Bacterial endotoxin and Microbial limit tests. Investigate the out of specification results and close out.
Perform risk assessments related to Microbiological activities. Should be a subject matter expert in method validations Sterility, Bacterial endotoxin test, Microbial enumeration test, test for specified microorganisms, Media , cultures, Growth promotion test, Microbiological analysis .
Moreover, you’re responsible to face external quality audits regulatory / customers’ audits hosting and audit management.
Key responsibilities & Accountability :
Accountable to prepare and execute method validation protocols and prepare summary reports.
Supervise and support in the Media preparation, Autoclaves operation, and growth promotion testing activities.
Supervise receiving and handling of cultures and culture suspension activities.
Should be able to analyze and / supervise antibiotic assay analysis.
Perform Microbiological analysis of raw material, packing material, in process, finished product and stability samples.
Prepare and update the SOPs, Validation protocols, STMs related to Microbiology.
Establish SOP's based on QMS, and revise them as necessary. Manage SOP's based on related procedures
Responsible for validation of equipment like Autoclave, Tunnel / DHS, LAF / Biosafety cabinets, Incubators, etc.
Responsible for Antibiotic assay and other microbiological validations like Disinfectant efficacy, Hold time studies.
Responsible for identification of isolates, preparation of isolate library.
Handle the team of Microbiologists and maintain the lab in compliance to requirements of cGMP, GLP and data integrity.
Perform GAP assessment and prepare risk mitigation plans.
Review and ensure that Microbiological analysis records are complete on day-to-day basis.
Accountable to train and qualify the microbiologists for different analysis.
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
Participate in continuous improvement initiatives.
Keep up to date with all relevant regulations (GXP, GMP, WHO, FDA, ISO etc.); in compliance with regulations.
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. Qualifications : - Education
Bachler degree in Microbiology / related Life sciences
Master degree in Microbiology is a plus - Experience : Experience of minimum 08 years in Pharmaceutical Industry preferably in Sterile formulations, with 2+ years as supervisory role in Pharmaceutical Microbiology from companies having GMP approval from highly regulated authorities like USFDA / MHRA / EU / TGA.
Previous experience in a similar role and with experience in a Pharmaceutical / Healthcare Industry is preferred.
Proven experience with SOP writing, GMP compliance, Method validations of Sterility, Bacterial endotoxin testing, Antibiotic assay, and in handling OOS results in Microbiological analysis, Water and Environmental monitoring - Training : Key Competencies :
In terms of Competency you are highly result oriented with strong sense of accountability & ownership,
Excellent communication, interpersonal and presentation skill.
High on process compliance & should have Solid Technical knowledge on regulatory guidelines and Pharmacopoeias with strong implantation 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.
Strong Team building skills and having effective team communication and motivational skills.
You are a team player with a proactive and collaborative approach and enthusiastically manage stakeholders in good spirit.
Technical Competencies : Extensive Knowledge in cGMP, GDP, PV and regulatory guidelines.