• Quality Analyst Jobs in Rajahmundry,India - 25080338

  • chrispy consultancy
  • Save Job
  • 5 - 10 Years
  • Posted : above 1 month

Job Description:

 Development Stage – During R&D, checking the qualification of raw material, vendors, testing methods, validation, document control, equipment calibration and operating procedures, personnel recruitment and training, data recording, clinical trials, formulation of API batches and more

•Manufacturing Stage – These are a few examples of the QA unit’s role during production

o Preparing, approving and monitoring the implementation of key documents (Quality Policy and Objectives, Quality Manual, Validation Master Plan, etc)

o Approving an equipment calibration, qualification and maintenance schedule, as well as critical utilities qualification calendar (HVAC, water, gas and power distribution systems, etc)

o Ensuring that specifications and test procedures for raw materials, packing materials, in-process testing, APIs, stability testing, etc are all in place

o Reviewing training records to check if on-the-job and induction training is taking place according to the schedule, and whether QC (Quality Control) analysts are being validated

o Ensuring that planned/unplanned changes or deviations are documented, reviewed and analyzed, and recommending studies, tests or validation activities to be performed

o Logging and responding to customer complaints, supervising the investigation into the cause of the issue, providing an investigation report to the customer, etc

o Initiating, documenting and investigating market returns, reprocessing (for API batches) or destruction (for finished batches), and informing regulatory authorities about defects found after distribution

o Training and leading the internal audit team for each department, interacting with auditors during external, internal and customer inspections, and intimating management of the observations

o Reviewing and approving manufacturing records and QC testing data before any intermediate, API or finished batch is released, as well as periodic trending of this data

o Initiating an OOS (out of specification) investigation and reviewing the QC test if any raw material, packaging, intermediate or stability sample does not meet established and approved specification during the latter

o Qualifying and auditing calibration service providers for tests and calibrations not performed in-house, reviewing and preparing Quality and Technical agreements for other manufacturing sites

QA System The Backbone of Pharma Quality





Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Healthcare
Functional Area : Bio Tech/R&D/Scientist, Quality/Process Control
Role : Laboratory work, Pharmacy, Quality Assurance/ Control,
Salary : Rs 5.00 - 34.00 Lacs p.a.
Deadline : 11th May 2020

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