Assistant Manager - QC Compliance

In this role, you will be responsible for ensuring online documentation in the QC & Microbiology department aligns with cGMP & GLP compliance. This includes overseeing necessary testing, evaluating records, and reviewing/approving specifications and test procedures for starting materials, in-process products, and finished products. You will also be responsible for checking and approving certificates of analysis and ensuring accurate online data recording during analytical testing. Your key responsibilities will include: - Reviewing and approving investigations related to incidents, deviations, OOS, OOT - Reviewing risk assessments for QC and Microbiology - Ensuring control and maintenance of documents as per regulatory requirements - Providing trainings on data integrity and established guidelines by regulatory authorities - Offering technical support to the QC & Microbiology teams - Reviewing and approving SOPs, qualification, and calibration documents - Supporting new product introductions related to impurity assessments - Reviewing analytical method validation protocols and reports - Verifying audit trial data of QC and Microbiology instruments - Preparing for audits The ideal candidate should have: - Regulatory exposure to EU/MHRA/USFDA audits - 10-12 years of experience in analytical quality assurance - Salary expectation: CTC 8-9 Lakhs OR Negotiable If you are looking for a role that involves overall QC/Micro compliance, this position could be a great fit for you. In this role, you will be responsible for ensuring online documentation in the QC & Microbiology department aligns with cGMP & GLP compliance. This includes overseeing necessary testing, evaluating records, and reviewing/approving specifications and test procedures for starting materials, in-process products, and finished products. You will also be responsible for checking and approving certificates of analysis and ensuring accurate online data recording during analytical testing. Your key responsibilities will include: - Reviewing and approving investigations related to incidents, deviations, OOS, OOT - Reviewing risk assessments for QC and Microbiology - Ensuring control and maintenance of documents as per regulatory requirements - Providing trainings on data integrity and established guidelines by regulatory authorities - Offering technical support to the QC & Microbiology teams - Reviewing and approving SOPs, qualification, and calibration documents - Supporting new product introductions related to impurity assessments - Reviewing analytical method validation protocols and reports - Verifying audit trial data of QC and Microbiology instruments - Preparing for audits The ideal candidate should have: - Regulatory exposure to EU/MHRA/USFDA audits - 10-12 years of experience in analytical quality assurance - Salary expectation: CTC 8-9 Lakhs OR Negotiable If you are looking for a role that involves overall QC/Micro compliance, this position could be a great fit for you.