Process Strategy Specialist

6 days ago

Shillong, Meghalaya, India beBeeQuality Full time ₹ 15,00,000 - ₹ 20,00,000

We are looking for a Process Strategy Specialist to support the maintenance of process control strategy and facilitate establishment of Quality Risk Assessment. The ideal candidate will have expertise in translation of process parameters and process control strategy into focused validation plans.

Key Responsibilities:

  • Sustain process control strategy by supporting the Product Steward.
  • Translate applicable process parameters and process control strategy into focused validation plan for process validation.
  • Provide technical expertise and facilitate establishment of Quality Risk Assessment as needed.
  • Support site validation planning by writing and maintaining master plans for processes, cleaning, packaging processes and ongoing verification for processes and cleaning as applicable.
  • Ensure that appropriate variables are identified for on-going monitoring as a contributor to quality risk management activities.

Laboratory Duties:

  • Comply with applicable GxP regulations, SOPs, HSE, ISEC, and other guidelines.
  • Maintain up-to-date documentation of laboratory work carried out including documentation storage and archiving.
  • Contribute to and maintain lab instructions, SOPs, templates.
  • Support qualification and calibration of lab / pilot equipment with accompanying documentation, schedule, and perform routine maintenance.
  • Contribute to the evaluation of new equipment.
  • Design, execute, and document experiments (formulation/analytical tests) for products assigned in the context of process transfer, process improvement, and process validation.
  • Prepare and review appropriate GxP documentation including change requests.
  • Participate in Tech Transfer activities from laboratory to industrial scale, support validation activities.
  • Identify improvement options of current processes, propose business cases.

Performance Metrics:

  • Meet established validation milestones according to approved validation plans.
  • Audit and inspection outcomes as a measure of validation compliance with global regulatory expectations.
  • Timing and quality of technical reports.
  • Timely and successful implementation of transfer activities.

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