Dear Candidate,

! We are hiring ! Officer - Documentation ! Ambernath Plant !

Role & responsibilities

Job Responsibilities / Deliverables

- Prepare and review BMR/BPR, Process Validation, Hold Time Study protocols/reports, and other manufacturing documentation.
- Ensure production and packing documents comply with cGMP and Right-First-Time (RFT) requirements.
- Maintain and control master documents and ensure timely availability of BMRs on the shop floor.
- Support documentation for optimization, validation, and commercial batches and incorporate required revisions.
- Coordinate with Manufacturing, QA, QC, Warehouse, Engineering, TT and RA for document preparation, review, execution, and closure.
- Initiate, track, and close Change Controls related to document revisions.
- Support documentation requirements for regulatory submissions and audits.




- Drive document standardization to minimize errors, deviations, and improve operational efficiency.

Qualifications & Requirements

- B.Pharm / M.Pharm
- Knowledge of Solid Oral Dosage (OSD) manufacturing and packing operations Granulation, Blending, Compression, Coating, Capsulation and Packing; exposure to Nasal operations preferred.
- Basic knowledge of QMS, Change Control, BMR/BPR and protocol preparation/review.
- Willingness to work in all shifts.

Interested candidate can share their resume on "[email protected]". Kindly do refer and share for better reach.

Thanks & Regards

Rahul Gupta

AM - HR

Rubicon Research Pvt Ltd.

https://www.rubicon.com/

📌 Officer - Documentation (Mumbai)
🏢 Rubicon Research
📍 Mumbai