Senior IPQA Lead — Quality Assurance Excellence

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

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.