Commissioning Qualification Validation

6 days ago

Thane, India Spectrumprogrow advisors pvt. ltd. Full time

Comprehend and implement internal standards & Guidelines while delivering any job task

Prepare/Review GMP documents (VMP, RA, URS) as per the international regulatory requirement for following equipment and systems of Oral Dosage, Injectable and Biotech formulation facility.
- Process equipment.
- HVAC system.
- Clean utility systems.

Prepare Commissioning & Qualification protocols (DQ, IQ, FAT, OC, PQ) as per the international regulatory requirement for following equipment and systems of Oral Dosage, Injectable and Biotech formulation facility.
- Process equipment.
- HVAC system.
- Clean utility systems.

Prepare/Review Commissioning Protocols/checklist for Utilities

Standardization of validation documents.

Supervise/witness qualification process at site.

Compile Final Validation documentation package.

Perform and support QA functions of Department

Plan subtask for self and subordinates and remain accountable for overall manhour expenses.

Conduct FAT, inspection of set-up / prepare Gap analysis report for core area of competence.

Conduct GxP Audits

Routine Correspondence with clients and all project stake holders effectively & impressively

Internal Correspondence (written) within department

Independently Clarify Client queries/comments technically in line with the regulatory / Standard international/ local guidelines

Project Monitoring & Control

Prepare and submit monthly Reports

Activity & resource Planning

Billing as per projections

Set PBIS/KRA for team

Identify training need for the team members and develop them for scope services

Keep the team motivated and remain responsible for team performance

**TECHINCAL SKILLS / COMPETENCES**

Knowledge and understanding of International Regulatory Guidelines and Regulatory requirements for CQV (USFDA, EU, ISPE, ICH etc.)

Experience of preparing qualification protocols for API, Oral Dosage, Injectable and Biotech formulation

Basic understanding of the following equipment and systems of API, Oral Dosage, Injectable and Biotech formulation facility from qualification point of view.
- Process equipment.
- HVAC system.
- Clean utility systems.

Experience of leading a team

Read and understand isometric, P&ID and as built drawings.

**Salary**: ₹40,000.00 - ₹60,000.00 per month

Schedule:

- Fixed shift

Ability to commute/relocate:

- Thane - 400601, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 7 years (preferred)
- CQV: 5 years (preferred)

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