Assistant Manager- DQA

Job Description

Role & responsibilities Prepare and Review SOPs and Guideline for DQA. Formulate Documentation Process for the Key divisions of SRD and ARD. Review documents with respect to drug substance such as protocols, SOPs, test methods, data COAs and report through collaborate with CRD, ARD, and QC scientists. Successfully manage and complete all Audits that come up from time to time and conduct periodic internal audits and ensure compliance as per regulatory requirements Review process development documents including KSM/KRM identification, specification proposal, analytical method development and validation reports, stability protocols& reports and safety studies. Handle Vendor Qualifications for KSM/KRM, Solvents etc. Ensure Regulatory compliance as per USFDA and other such regulatory bodies. Support and handle all aspects pertaining to new product development patent filing, license approvals etc Impart training to all employees on SOPs/Safety. Support on Onboarding on new employees joining the organization Responsible for assessing the impact, review and closure of change control requests and deviations. Responsible for CAPA implementations, verifications of and effectiveness. Preferred candidate profile Bachelors or Masters degree in Pharmaceutical Sciences, Chemistry, or related field. Minimum 5-8 years of experience in Quality Assurance, with at least 2 years in a supervisory role in the pharmaceutical industry, specifically with API products. In-depth knowledge of GMP, ICH guidelines, FDA, EMA regulations, and quality systems. Proven experience in conducting internal and external audits, and leading regulatory inspections. Strong understanding of the API development and manufacturing process. Ability to manage cross-functional teams and interact with senior management