Biological E. Limited is hiring M.Pharmacy/ B.Pharmacy/M.Sc for Asst. Manager/Deputy Manager

Biological E. Limited is hiring for#QA-CMO#, PharmaSGI-USFDA Approved plant, Shamirpet location, Hyderabad.

Position: Asst. Manager/Deputy Manager

Qualification: M.Pharmacy/ B.Pharmacy/M.Sc

Experience(Injectables): 9 to 13 years

Job Description:

*Support and monitor development activities at Contract Development Organizations (CDO) and manufacturing at Contract Manufacturing Organizations (CMO).

*Provide quality oversight at CDO sites, including review of formulation and development documents, protocols, reports, and specifications.

*Review Pharmaceutical Development Reports, FRD, and PRD specifications and collaborate with R&D teams.

*Ensure quality oversight at CMO sites, reviewing Technology Transfer Dossiers, process validation batches, and stability studies.

*Review and approve exhibit batch records, protocols, and commercial batch documentation for compliance and batch release.

*Provide CMC documentation for regulatory filings and handle customer QMS notifications.

*Review and approve artwork and packaging documents, ensuring cGMP compliance at CMO sites.

*Prepare and review guidelines, SOPs, protocols, and reports for CM activities.

*Support audit management activities and notify senior management of quality issues within timelines.

*Review electronic data and audit trails to ensure data integrity.

*Good writing and speaking skills in English are mandatory.

Interested aspirants with relevant skills set can share their resumes to TA.Pharma@biologicale.com