Executive - Documentation

Rubicon Research; Mumbai; On-site; INR 450,000 - 650,000; Full time

Job summary

Rubicon Research Pvt Ltd. is hiring for an Officer / Executive - Mfg Documentation at Ambernath Plant. The role focuses on documentation, protocol preparation, and ensuring adherence to cGMP norms across production and packing activities.

Responsibilities include optimizing documentation workflows, coordinating with QA/QC and engineering, and closing change controls on time. B. Pharm / M. Pharm graduates are preferred, with strong knowledge of BMR/BPR and QMS processes.

Qualifications

• Knowledge of QMS/documentation and change control processes.
• Familiarity with BMR/BPR preparation and review.
• Understanding of cGMP norms in manufacturing environments.

Responsibilities

• Prepare and review documentation and protocols, including BMR/BPR and PVP/PVR.
• Streamline documentation workflows to improve productivity and traceability.
• Ensure documentation consistency to reduce errors and deviations.
• Coordinate across Manufacturing, QA, QC, Warehouse and Engineering for timely document closure.
• Initiate and track change controls related to document revisions and regulatory submissions.

Skills

Documentation

Change control

QMS

GMP knowledge

Education

B. Pharm / M. Pharm

Job description

Dear Candidate,

! We are hiring ! Officer / Executive - Mfg Documentation ! Ambernath Plant !

Role & responsibilities

1. Documentation & Protocol Preparation

• Preparation and review of following document
• Batch Manufacturing Records (BMR)
• Batch Packaging Records (BPR)
• intended batch BMR/BPR.
• Process Validation Protocols/Reports (PVP/PVR)
• Hold Time Study Protocols/Report (HTSP/HTSR)
• Review and control of documentation to ensure consistency in manufacturing thereby reducing errors and deviations.
• Drafting and maintenance of master records.
• To ensure the document for production & packing activities adhering to cGMP norms and right at first time.

2. Operation Efficiency

• Streamline documentation workflows to improve productivity, traceability, and accountability across departments.
• Submit BMR requests to QA and ensure that BMRs are available on the shop floor before starting production.
• Provide suggestions with respect to documents for improving productivity, safety, and cost efficiency.
• Monitor and control the manufacturing process with respect to documentation for each optimization, validation, and commercial batch, incorporating provided technical inputs and implementing document changes as and when required.

3. Process Standardization

• Review and control documentation to ensure consistency in unit operation, thereby reducing errors and deviations.
• Communicate with the client or the TT/RA to obtain any missing documents or required information.
• Ensure closing validation reports on time.

4. Coordination & Cross-Functional Support

• To co-ordinate Manufacturing, QA, QC, Warehouse, and Engineering to ensure smooth and timely execution of documents and closing of document revision change control.
• Arrange all necessary documents prior to batch execution.
• Co-ordinate with QA and cross-functional team to review the document and ensure that BMR/Documents are available on the shop floor before starting production

5. Change Control

• Initiate, track, and ensure the timely closure of Change Controls related to document revisions.
• Assist in the preparation of data and documents for regulatory submissions and audits.

Qualifications & Pre-Requisites

• B. Pharm / M. Pharm
• Knowledge of unit operations involved in manufacturing and packing of solid oral dosage forms i.e. Granulation, Blending, Compression, Coating, Capsulation, Packing etc. and nasal operations.
• Basic knowledge of QMS/documentation (change control, document/Protocol/BMR/BPR preparation/review etc.)

Additional notes:

• Role is expected to work in all shifts.

Regards

Rahul Gupta

Assistant Manager - HR

Rubicon Research Pvt Ltd.