Assistant Manager / Deputy Manager / Manager

Role & responsibilities

• 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.