Documentation Executive| Kaisha Pharma Pvt Ltd-Daman

Kaisha Pharma Pvt Ltd; Dadra and Nagar Haveli and Daman and Diu; On-site; INR 350,000 - 550,000; Full time

Job summary

Kaisha Pharma Pvt Ltd is seeking a detail-oriented Production Documentation specialist to manage batch records, GDP compliance, and document control in our manufacturing facility.

You will prepare and review BMRs/BPRs, maintain glass vial, ampoule, and cartridge records, ensure data integrity, and coordinate with QA, QC, and engineering for audits.

The role requires meticulous record-keeping, timely reporting, and adherence to SOPs and regulatory standards.

Qualifications

• Good 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.

Responsibilities

• 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.
• Maintain and verify documentation related to glass tube cutting and preparation, vial, ampoule, and cartridge forming operations, annealing and other thermal processes, inspection and packing records.
• Document control and record management: maintain formats, logbooks, checklists, and registers; ensure SOPs are available; coordinate with departments; file and archive.

Skills

Written communication

Attention to detail

Data integrity

Documentation control

Coordination with ops

Time management

Confidentiality

Job description

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

• Good 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.