Roles and Responsibilities:
- Developing and integrated system meeting the regulatory expectations in terms of USFDA, KFDA,EDQM, WHO-GMP, ANVISA, ISO, etc. quality standard and customer expectations.
- Inspection-ready for quality systems (Regulatory, GMP and customer).
- Preparation and response to audit compliance and supporting necessary documentation.
- Quality Risk Assessment of the Process and system with conducting Gap analysis as per guidelines.
- Professionally and mentally strong expertise in the area of validations (cleaning, process, analytical, computerized system, utilities and etc.), assessment of changes, investigations, audit compliance and etc.
- Periodic conduct of Internal Audits to assess the status of integrity of expected system meeting certain standard as adopted by the organization, deployment of systems and take corrective / preventive measures for achieving organizational objectives for continual improvement.
- Strong knowledge on the all functions (departmental systems) and problem solving skills with using my qualified experience and communication skills.




- To organize / conduct training programs to the senior and junior level employees to develop the quality management system and culture.
- Handling of qualifications, product reviews, OOS, OOT, CAPA, deviations, change controls,
- documentation (procedures, protocols, reports, setting of product specifications, testing
- methods), training, market complaints, batch review, release /distribution, investigations,
- preparation of master validation policy and its implementation, water validations, vendor
- qualification and audits, stability program and assigning re-test period / shelf life of product,
- SMF, various manuals etc.
- Planning and execution of Analytical Method validations and Analytical method transfers for the parameters using analytical methodologies as per regulatory requirements.
- Identifying scope for Planning, implementing & monitoring of technological changes to e

📌 Agm-qa (Rpl) (Visakhapatnam)
🏢 Rakshit Group Of Companies
📍 Visakhapatnam