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 robust 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.
Solid 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