Rubicon Research - Assistant General Manager - Quality Assurance/Validation

We are hiring Assistant General Manager for our Ambernath plant who has experience in validation & qualification.

Below is the JD for understanding:

- To ensure cGMP Compliance as per laid down procedures.

- Execute and Monitor key QA activities - Process validation, Cleaning Validation, Equipment Qualification, Instrument Qualification, Utility 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.