Assistant Manager - QC Compliance

As a Quality Control & Microbiology Department Manager, your role involves ensuring online documentation compliance with cGMP & GLP standards. You will be responsible for overseeing testing procedures, reviewing specifications, and approving necessary documentation. Your key responsibilities include: - Ensuring all testing is conducted according to approved specifications and standard procedures - Reviewing and approving specifications and test procedures for starting materials, in-process, and finished products - Checking and approving certificates of analysis for raw materials, in-process samples, packing materials, and finished products - Supervising online data recording during analytical testing - Developing and implementing SOPs in alignment with cGMP & GLP requirements - Monitoring QC personnel to ensure adherence to job responsibilities - Reviewing and addressing investigations related to incidents, deviations, OOS, OOT - Conducting Risk Assessments for QC and Microbiology - Managing document control as per regulatory requirements, including raw data, SOPs, and training charts - Providing training on data integrity and regulatory guidelines - Offering technical support to QC & Microbiology departments - Reviewing and approving SOPs, qualification, and calibration documents - Supporting new product introductions related to elemental and Nitrosamine impurity assessment - Validating analytical methods and verifying instrument audit trial data - Preparing for audits Qualifications Required: - Regulatory exposure to EU/MHRA/USFDA audits and experience in analytical quality assurance - 10-12 years of relevant experience - CTC: 8-9 Lakhs or Negotiable You will play a crucial role in ensuring overall QC/Micro compliance.,