Section Head-IPQA-Rubicon Research (Satara)

7 - 12 years

5 - 10 Lacs

Posted:2 days ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

To ensure cGMP Compliance as per laid down procedures.

  • Monitoring overall all QA activities - Process validation, Cleaning

Validation, Equipment Qualification and Master Document review.

  • Preparation and review of SOPs applicable to QA.
  • Evaluation of QMS documents.
  • Preparation of Validation Master Plan, review of process validation,

equipment qualification and cleaning validation protocols and

reports

  • Participate in investigations and review of investigations.
  • Monitoring of Exhibit and Submission batches documentation and

Coordination with RA for document submission

  • Monitoring of document control, storage, and archival.
  • To provide training to QA team members and other functions.
  • Participate in customer and regulatory inspections and ensuring

CAPA effectiveness.

  • Participate in self-inspections. To audit the internal quality system

as a part of self-inspection (internal audit).

  • Timely and proactively escalating issues.

Preferred candidate profile

Candidate must have experience of shop floor working, in-process quality assurance, Process Validation, Cleaning Validation, Equipment

Qualification and ability to handle the team. Preferably form Liquid Oral/ potent formulation/ OSD.

Interested candidates may apply on

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