Senior Manager - IPQA Lead

Sun Pharmaceutical Industries, Inc.; Indiana (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in the United States seeks an experienced QA professional to oversee batch release, cGMP compliance, and QA documentation. The role covers review and approval of qualification protocols, investigations, and CAPA to ensure timely product release.

Educational background includes M.Sc, B.Pharm or M.Pharm with 15–18 years of injectables regulated site experience. Strong collaboration with planning, QC, regulatory affairs, and engineering is required.

Qualifications

• M.Sc / B.Pharm / M.Pharm degree required.
• Experience in injectables regulated sites is essential.
• Strong knowledge of cGMP, QA and batch release processes.

Responsibilities

• Ensure batch production records are executed and reviewed per SOPs and cGMP.
• Release or reject batches after review of quality documentation.
• Conduct certification of BPR after batch completion.
• Review and approve equipment qualification protocols and reports.
• Review annual product review reports as per schedule.
• Track deviation and investigations related to product release.

Skills

cGMP

QA

Batch Release

Audit

Education

M.Sc / B.Pharm / M.Pharm

Tools

Trackwise

Job description

Company: Sun Pharmaceutical Industries Ltd

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:

• Ensure that batch production records are executed and reviewed in accordance with established SOPs and cGMP regulations.
• To release / reject the Batch after complete review of batch and related quality documentation.
• Conduct certification of BPR after completion of batch.
• Review and approve equipment qualification protocols and reports for accuracy, completeness, and traceability as well as adherence to protocol / procedures.
• Review and approve Annual Product review reports for the products as per the schedule.
• Track to completion all deviation and investigations related to product release.
• Conduct thorough investigations into and complaints for products manufactured at the site and ensure on-time closure of complaints.
• Run reports in electronic systems to ensure that all requirements related to batch release are met.
• Work directly with planning, QC, other QA functions, and Regulatory Affairs to ensure batches are released to meet supply chain requirements.
• Participate in self-audits of facility and equipment in partnership with Manufacturing and Engineering to ensure readiness for operations.
• Identify continuous improvement opportunities to increase compliance, process clarity, and operational efficiency.
• Review and approve Master Formula (Manufacturing / Packing Instruction) and SOPs.
• Review and approve process validation protocols and reports for accuracy, completeness, and traceability and well as adherence to protocol / procedures.
• Review and approve of QMS records in Trackwise system and ensure timely closure.
• To monitor timely initiation and completion of individual steps as per the work flow for all tackwise records.
• Co-ordination and compilation of sampling and testing for Beta lactam monitoring & cleaning validation/verification periodic and routine monitoring in Block.
• To ensure assessment is performed with respect to cross contamination/ Cleaning validation for new products introduced in block.
• Provides appropriate training and development to support staff to meet their respective job responsibilities.
• Work in partnership with manufacturing, Engineering, and QC to increase knowledge and understanding of cGMP’s and improve practices and procedures.
• To ensure that the required initial and continuing training of quality unit personnel is carried out as per assigned Job role or responsibilities.
• To ensure that all the equipment and instruments used in manufacturing and in process test are Qualified, Periodically Calibrated and Preventive maintenance performed as per schedule.
• Establishment, implementation and maintenance of the quality system in area.
• To participate in External and Internal audit, provide timely response with appropriate corrective action.

To ensure that In process, finished product, Process Validation and stability samples are withdrawn in a timely manner as per sampling plan .

Job Requirements

Educational Qualification

M.Sc / B.Pharm / M.Pharm

Experience

Tenure: 15 to 18 Yrs (with Injectables regulated sites)

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).