Rakshit Pharmaceuticals Limited hiring Sr. Manager/ AGM – QA department

Rakshit Pharmaceuticals Limited hiring Sr. Manager/ AGM - QA department

Job openings for QA @ Rakshit Pharmaceuticals Limited

Department: Quality Assurance
Designation: Sr. Manager or AGM
Experience: 16 – 20 Years
Vacancies: 01
Location: Visakhapatnam
Salary: ₹ 17,00,000 – 22,50,000 P.A
Core Competences:

  • Developing and integrated system meeting the regulatory expectations in terms of USFDA, EDQM, WHO-GMP, ANVISA, ISO 9001:2008 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 professional experience and communication skills.
  • To organize / conduct training programs to the senior and junior level employees to develop the quality management system and culture.

Proficient in day-to-day Quality assurance activities which includes:
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
a) Planning, implementing & monitoring of technological changes to enhance operational
efficiency.
b)Modifications in process, process flow, working practices, consumables, etc. for
controlling failures.

  • Implementing various techniques for cycle time reduction, entailing identification of opportunities, and analysis of data, conduction of tests, cost benefit analysis, implementation and post audits.
  • Executing cost saving techniques / measures and modifications to achieve substantial reduction in expenditures and work within the budget.
  • Executing cost saving techniques / measures and modifications to achieve substantial reduction in expenditures and work within the budget.

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