Role & responsibilities

A. Production Documentation

- Prepare, issue, review, and maintain Batch Manufacturing Records (BMRs) and Batch Production Records (BPRs), as applicable.
- Maintain production records for glass vial, ampoule, and cartridge manufacturing processes.
- Record daily production output, rejection, breakage, yield, and production losses.
- Ensure all production entries are complete, accurate, legible, and recorded at the time of activity.
- Verify machine-wise and shift-wise production reports.
- Maintain records of line clearance, equipment cleaning, and production activities.

B. Good Documentation Practices (GDP)

- Ensure compliance with GDP, GMP, and ALCOA+ data integrity principles.
- Verify that corrections are made properly, with signatures, dates, and reasons wherever required by the applicable procedure.
- Ensure that overwriting, backdating, and unauthorized alterations are avoided.
- Check that all records are properly signed, dated, and reviewed by authorized personnel.
- Maintain document traceability and prevent the use of obsolete documents.

C. Production Process Documentation

Maintain and verify documentation related to:

- Glass tube cutting and preparation, where applicable.
- Vial, ampoule, and cartridge forming operations.
- Annealing and other thermal processes.
- Inspection, sorting, and rejection records.
- Dimensional and visual inspection records, where applicable.
- Packing, labelling, and finished-goods transfer records.
- Equipment usage, cleaning, and preventive maintenance records relevant to production.

D.



Document Control and Record Management

- Maintain controlled formats, logbooks, checklists, and registers.
- Ensure the latest approved SOPs and formats are available at the production area.
- Coordinate with Production, Quality Assurance (QA), Quality Control (QC), and Engineering departments for documentation-related issues.
- File completed batch records and other documents in designated locations.
- Maintain document issuance, retrieval, archival, and record-retention registers as applicable.
- Support internal, customer, and regulatory audits by retrieving required records.

E. Reporting and Coordination

- Prepare daily, weekly, and monthly production reports.
- Compile data related to production quantity, rejection percentage, yield, and downtime.
- Follow up with production supervisors for missing entries, signatures, and incomplete records.
- Assist in the preparation and revision of SOPs, work instructions, and production formats.
- Support investigations and documentation for deviations, non-conformances, and CAPA as assigned.
- Ensure timely submission of production documents to the concerned department.

Preferred candidate profile

- Positive written communication and record-keeping skills.
- Attention to detail and accuracy.
- Knowledge of document control and data integrity.
- Ability to coordinate with production operators and supervisors.
- Time management and record retrieval skills.
- Ability to maintain confidentiality and follow established procedures.

📌 Documentation Executive| Kaisha Pharma Pvt Ltd-Daman (Dadra and Nagar Haveli and Daman and Diu)
🏢 Kaisha Pharma
📍 Dadra and Nagar Haveli and Daman and Diu