Role & responsibilities Responsible for microbiology lab activities & compliance Environmental Monitoring Risk Assessments/ rationales and area qualificationEnsuring timely release of all microbiological tests thereby meeting company targetsHandling of QMS activities like Change Controls, Incident, OOS and OOL investigations and impact assessmentsReview/ 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 documentsResponsible for participation / evaluation of Risk Assessments/ impact assessments wherever applicableReview/approval of trends as applicable and to recommend any changes for the better control of the systemResponsible to handle internal and external audits and coordinate with all cross functional teams for better productivity and qualityResponsible to take the lab rounds on daily basis and correct the non-compliance if found any and to find out the opportunities for improvementsImprovement of quality culture in the team and ensuring the safety in the labEnsuring the compliance to Audit observations related to microbiologyRegular updates to QC Head about incidents, OOS and CAPA'sTo ensure strict adherence to safety & cGMP all factory and maintain the data integrity in the microbiology labAbility to work independently and as part of a teamPreferred candidate profile Candidates with minimum 8 - 12 years experience from Pharmaceutical industry (formulation / topical background preferred)