Quality Assurance Manager /deputy Manager

Disha HR Solution

to Plan and Direct the Analytical Activities Related to Semi-finished Product, Finished Products, Raw Materials, Packing Materials ,Microbiology, Stability and Environmental Samples and to Ensure that Testing is Executed in a Timely and Cglp, Cgmp Compliant Manner.

to Perform the Review of Analytical Results Generated in the Laboratory and Make Decisions On Acceptability of all Test Results.

to Ensure Laboratory Testing of Components, Containers, In-process Materials, Packaging Materials and Drug Product is Performed Using Scientifically-derived, Fit-for-purpose/validated Analytical Method.

• to Manage the Qualification, Calibration and Preventive Maintenance of Laboratory Instrumentation and Related Computer Systems.

• to Develop and Implement a Comprehensive Training Program for the Laboratory Personnel.

• to Perform Critical Review and Approval of Quality Control Documentation (. Coas, Reports, Protocols).

• initiate and Facilitate Timely Investigations of Out-of-specification and Out-of-trend Data, Lab Incidences and Communicate Effectively and Timely to Head Qa. Assist in Determining Root Causes and Appropriate Capas.

• to Incorporate Statistical Tools for Evaluation of Data, Sampling Plans, Stability Reports, Product Shelf Life, and Investigations.

• to Assure that Qc Lab Operate in a Safe, Clean and Environmentally Sound Manner.

• to Co-ordination with External Agencies Related to Annual Maintenance Contract and Spares Management.

• responsible for Reagent, Hplc Column and Chemicals Inventory.

• to Carry Out Any other Function Given to You By Your Superiors from Time to Time.

• support Continuous Improvement of Lab Processes for Increased Efficiency.

• to Ensure all Personnel Working in Qc are Properly Trained.

• to Report Daily to Head Quality Assurance.

• to Ensure Implementation of Quality Systems, Current Gmp & Glp Norms in Manufacturing.

• Experience

  12 - 20 Years

• No. of Openings

  1

• Education

  M.Sc

• Role

  Quality Assurance Manager

• Industry Type

  Pharma / BioTech / Clinical Research

• Gender

  [ Male / Female ]

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office