Development Quality Assurance Manager

Synergene Active Ingredients

5 years

0 Lacs

Hyderabad Telangana India

Posted:2 months ago| Platform:

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Skills Required

development reports manufacturing compliance support technology management controls data integrity documentation audits coordination qc api communication training

Work Mode

On-site

Job Type

Full Time

Job Description

Job Summary L ooking for a Development Quality Assurance Executive/Sr. Executive with a minimum of 5 years experience in the pharmaceutical industry. Responsibilities and duties Review and approval of development-related documents (e.g., process development reports, analytical method validation, exhibit batch records). Quality oversight of lab-scale, pilot-scale, and exhibit batch manufacturing to ensure GMP compliance. QA support during technology transfer from R&D to manufacturing. Management of change controls, deviations, and CAPAs for development activities. Review of process validation and analytical method validation data. Ensure data integrity and documentation compliance (as per ALCOA+). Support for audits, inspections, and regulatory submission readiness. Cross-functional coordination with R&D, QC, Production, and Regulatory Affairs. Required Experience, Skills and Qualifications B.Pharm / M.Pharm / M.Sc. in Chemistry, Pharmaceutical Sciences, or related field. 5–9 years of experience in Development QA (preferably in an API manufacturing environment). Strong understanding of cGMP, ICH guidelines, and regulatory requirements (USFDA, EMA, etc.). Excellent documentation, communication, and analytical skills. Benefits Competitive wages and benefits Increments every year based on performance Training Show more Show less

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