Senior Manager Quality Control | Sun Pharma | Sikkim

Job Description

Senior Manager Quality Control

Business Unit: Global Quality & Compliance

Location: Sikkim

Job Responsibilities:

• Management of QC operations for receipt, testing, and approval/rejection of all incoming materials, In-process Products, and Finished Products.
• Ensure analysis of test samples as per approved Standard Test procedure for Raw Materials, Packing Materials, Stability Samples, Process Validations, In-Process Samples, and Finished Products.
• Ensure maintenance of Reference Standards, Working Standards, and other standards are required in QC.
• Compliance to documentation as per SOP on Good Documentation Practices and cGMP Guidance for documents taken in Laboratory Control and Management.
• To ensure that all analysts are trained on SOP, General procedures and are qualified as applicable.
• Ensure that analytical data is reviewed by the analyst/reviewer. In case of any Lab Deviation with respect to procedure, it is investigated and documented.
• Ensure that testing labs were approved and contracts for analysis were available before utilizing services.
• Ensure all reference standards, cultures are procured from authorized/Pharmacopoeial distributors and approved vendors wherever applicable.
• To investigate any lab deviation, OOT, and OOS cases reported and implemented CAPA.
• Jointly responsible with QA to take part in disposition decision of OOT and confirmed OOS of raw materials, in-process products, and finished Products.

Educational Qualification – M.Sc – Organic Chemistry

Experience – 18 to 20 Yrs

Location – Sikkim