Production Head (API)

SUN PHARMA; Town of Florida (NY); On-site; USD 31,000 - 57,000; Full time

Job summary

Sun Pharma is seeking a Production Head to lead manufacturing across all commercial blocks in an API plant. The role requires deep cGMP and FDA regulatory knowledge, with extensive leadership of process optimization and CAPA activities.

You will oversee batch records, document control, and budgeting while driving continuous improvement and staff development in a highly regulated environment.

Qualifications

• Tenure: 20–25 years in API plant with strong knowledge of cGMP and FDA regulations.
• MSc./B.Tech in Chemical Engineering.
• Experience with quality systems, CAPA processes and regulatory readiness.

Responsibilities

• Manufacture activities across all commercial blocks; meet production plan with quality and cost targets.
• Ensure documents are up-to-date; review SOPs, BPRs, and BRCs.
• Lead CAPA actions; review MPRs/ECRs in eBMR; ensure GMP compliance.
• Manage CAPA investigations, calibrations, and equipment maintenance.
• Prepare annual budget; drive cost efficiencies and yield improvements.
• Train and develop subordinates; maintain disciplined industrial relations.

Skills

cGMP knowledge

FDA regulations

Process optimization

Quality systems

Education

MSc./B.Tech (Chemical)

Tools

SAP

TrackWise CAPA

LMS

DCM

Job description

Job Title

Job Title

Production Head

Business Unit

Production

Job Grade

DGM / GM

Location

Toansa

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Key Responsibilities

• Responsible for manufacturing activities of all commercial manufacturing blocks. Ensuring delivery of scheduled production as per plan meeting quality and cost parameters. Ensuring projects are completed within timeframe and allocated resources. Evaluating opportunities for reduction of waste generation, water wastage and fugitive emission.
• Ensuring availability and updating of relevant process, regulatory, statutory and engineering documents.
• Ensuring production activities are performed as per approved procedures.
• Ensuring manufacturing cost within standard yields and usages.
• Continuous improvement of manufacturing processes.
• Issuance of Batch Production Records and Batch Record of Cleaning.
• Reviewing all Batch Production Records and BRC.Approval of MPRs/ECRs in eBMR printing module.
• Review of new/revised MPRs and validation protocols and reports.
• Performing authorized SAP, TrackWise CAPA, LMS and DCM activities.
• Reviewing and approving SOPs.
• Preparing and reviewing risk assessments.
• Reviewing trends of quality and production parameters. Ensuring production deviations are evaluated and investigated.
• Investigating OOS, Market Complaints and OOT.Planning and implementation of CAPA actions. Ensuring necessary calibrations and records are maintained.
• Ensuring timely maintenance of equipment and facilities.
• Evaluating proposed changes for quality and productivity improvements. Qualifying new or modified facilities and equipment.Ensuring compliance to cGMP, safety procedures and statutory guidelines.
• Training and development of subordinates.
• Maintaining discipline and harmonious industrial relations.
• Verification of document destruction records.
• Preparation and maintenance of annual budget.
• Ensuring manufacturing efficiencies as per budget plan.
• Maintaining product quality and yield as per norms.
• Practicing company values in all aspects of work.
• Preparation of product development and cleaning procedure development reports.
• Ensuring production facilities are clean and disinfected where required.
• Review of Operating Manual.
• Sign-off documents/TrackWise records as HOD/Function Head.
• Ensure batch production order verification before issuance.
• Ensure equipment calibration, qualification and maintenance.
• Ensure controlled issuance, revision, replacement and distribution of documents.
• Ensure availability of specifications, analytical methodologies and acceptance criteria.

Travel

Estimate

Job Requirements

Educational Qualification

M.Sc./B. Tech (Chemical)

Experience

Tenure : 20 - 25 Years in API Plant, Strong knowledge of cGMP, FDA regulations, and industry best practices

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).