Job Description

Department:

Production

Reporting To:

Manager - Production

Industry:

Pharmaceutical / Sterile Manufacturing

Experience:

5-10 Years

Qualification:

ITI / Diploma / B.Pharm / B.Sc. (Technical)

Job Summary

Responsible for optimizing BFS production processes through effective supervision, preventive and breakdown maintenance, and robust documentation practices. The role ensures smooth production operations, high equipment availability, compliance with cGMP requirements, and readiness for regulatory audits.

Key Responsibilities:

1. Production Process Optimization

Improve production efficiency through

routine inspections, preventive maintenance, and calibration

to minimize downtime. Supervise

daily BFS production activities

to ensure operational efficiency and output quality. Collaborate with

cross-functional teams

(QA, QC, Engineering, Validation) to optimize manufacturing processes and resolve technical issues. Coordinate production engineering activities to ensure

consistent and high-quality output

.

2. Equipment Maintenance & Troubleshooting

Perform

preventive and breakdown maintenance

of

BFS (Blow-Fill-Seal) machines

. Execute routine maintenance activities such as

lubrication, inspection, alignment, and minor repairs

. Troubleshoot and diagnose

complex mechanical, electrical, and process-related issues

to ensure uninterrupted production. Conduct regular equipment inspections and recommend

maintenance improvements or upgrades

. Maintain detailed

maintenance records

, including repairs, spare parts usage, and machine history. Perform

mould changeovers

for different pack sizes (500 ml, 250 ml, and 100 ml).

3. Documentation Management

Prepare, review, and update

Standard Operating Procedures (SOPs)

related to production and maintenance. Prepare

Master Preventive Maintenance Plans

for production equipment. Maintain and review

equipment operation and preventive maintenance logbooks

. Review filling-related sections of

Batch Manufacturing Records (BMRs)

for accuracy and compliance. Ensure proper

archiving, traceability, and retrieval

of documents for audits and inspections. Prepare and support documentation for

regulatory audits and inspections

. Review documentation for

accuracy, completeness, and GMP compliance

. Coordinate with

Quality Assurance (QA)

for deviations, change controls, and

CAPA

activities. Ensure batch records are

properly reviewed and completed

prior to product release.

4. Coordination & Communication

Work closely with

Production, QA, QC, and Validation teams

for smooth operations and documentation flow. Support investigations related to

deviations, non-conformances, and customer complaints

. Provide

training to operators and staff

on equipment operation, documentation practices, and GMP compliance. Identify and implement

continuous improvement initiatives

in production and documentation practices. Stay updated with

current regulatory guidelines and industry trends

related to sterile manufacturing and documentation. Support

internal and external audits

by providing required documentation and technical explanations.

Machine Exposure / Hands-on Experience

STERIMAX BFS 8166

STERIMAX BP 360

BREVETTI ANGELA SYFPAC BFS Machine

BFS 7510

HUNAN GLADDEN ISBM Machine

Key Skills & Competencies

Strong expertise in

BFS technology and sterile manufacturing

In-depth knowledge of

preventive & breakdown maintenance

Excellent

GMP documentation and audit readiness

Problem-solving and root cause analysis skills Effective communication and team coordination Ability to train and mentor technical staff
Job Types: Full-time, Permanent

Pay: ₹30,000.00 - ₹50,000.00 per month

Benefits:

Health insurance Provident Fund
Work Location: In person