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
ABAC
