Job Description

Role & responsibilities Responsible for microbiology lab activities & compliance Environmental Monitoring Risk Assessments/ rationales and area qualification Ensuring timely release of all microbiological tests thereby meeting company targets Handling of QMS activities like Change Controls, Incident, OOS and OOL investigations and impact assessments Review/ approval of protocols and reports of analytical method development, method suitability studies, process validations, Instruments/equipment qualifications and various miscellaneous microbiological validation/ activities and analytical documents Responsible for participation / evaluation of Risk Assessments/ impact assessments wherever applicable Review/approval of trends as applicable and to recommend any changes for the better control of the system Responsible to handle internal and external audits and coordinate with all cross functional teams for better productivity and quality Responsible to take the lab rounds on daily basis and correct the non-compliance if found any and to find out the opportunities for improvements Improvement of quality culture in the team and ensuring the safety in the lab Ensuring the compliance to Audit observations related to microbiology Regular updates to QC Head about incidents, OOS and CAPA's To ensure strict adherence to safety & cGMP all factory and maintain the data integrity in the microbiology lab Ability to work independently and as part of a team Preferred candidate profile Candidates with minimum 8 - 12 years experience from Pharmaceutical industry (formulation / topical background preferred)