Asst. Manager

We have an urgent opening for the position of Asst. Manager / Manager – Quality Assurance Auditor for a leading producer of specialty chemicals for the Ambernath location.

Designation: Asst. Manager / Manager – Quality Assurance Auditor

Job Location: Ambarnath

Education: M.Sc./ B.Sc. with any Specialization Certificate in Pharma Audit

 Skills: Familiar with applicable and appropriate regional regulations (e.g., FDA and other regulatory agency guidelines, thorough working knowledge of ISO, cGMPs (Good Manufacturing Practices), and SOPs (Standard Operating Procedures).

Job Summary: Candidate should have B. Sc or M. Sc with any Specialization Certificate in Pharma Audit from a reputed university/Institute with a minimum of 5 years of Experience in Quality assurance & Audit areas.

Experience should be in audit preparation for pharma manufacturing companies.

Role & Responsibility:

•  Candidates have to handle ISO, cGMP, and potential FDA audit independently.
•  Design and execute a complete Quality System consisting of procedures to streamline daily manufacturing operations necessary to produce a quality product.
•  Ensure quality control and assurance procedures are adhered to upon receiving incoming raw materials and consequent manufacturing operations.
•  Assess and test the quality of materials to validate analysis certificates using wet chemistry and instrumentation techniques.
•  Assisted management in the continuous improvement of process and product quality by analyzing incoming, final product, and customer samples.
•  Record/track quality assessment scores and provide feedback to reduce errors and improve processes and performance to ensure the quality of the network.
•  Ensure appropriate decisions are made regarding the quality characteristics of products, materials, and equipment.
•  Report findings to management, if it is of safety concerns, do so immediately.