Assistant Manager

PurposeEnsuring seamless coordination with Contract Manufacturing Organizations for commercial and development products, compliance with regulatory and GMP requirements, timely supply, and effective issue resolution. Increasing product portfolio and multi-CMO engagement requires dedicated operational oversightPosition / Job TitleSr. Executive to Asst. ManagerDepartmentCorporate Quality Assurance (CQA)Reporting ToSenior ManagerLocationThane, MumbaiYears of Experience09 to 11 yearsDosage FormKnowledge of injectable / topical / ophthalmic formulation expertise in formulation know howJob Responsibilities / Deliverables

• CMO Quality Oversight & Compliance
• Act as Quality SPOC for assigned CMOs; ensure adherence to Quality Agreements and regulatory commitments.
• Perform periodic CMO performance evaluations through risk-based monitoring.
• Support vendor qualification, requalification & capability assessment as per QMS
• Onsite visits to CMO's on periodic basis to monitor batch execution, troubleshooting discrepancies in batch execution and review of documents
• QMS Coordination and Release Support
• Monitor and track quality events at CMO's including - Deviations, Change Controls, OOS/OOT, CAPA, Market Complaints
• Ensure timely batch documentation review and batch release activities
• Escalate critical issues to Management through Quality Risk Management forum
• Close coordination with internal CMO management team to achieve organization goals from CMO
• Audit, Inspection & Regulatory Compliance
• Support internal audits and participate in external regulatory inspections at CMOs.
• Ensure implementation and follow-up of audit findings and regulatory commitments.
• Maintain inspection readiness and documentation availability.
• Documentation & Lifecycle Management
• Review validation documents, BMR/BPR, PQR/APQR data, stability & product lifecycle records
• Ensure GDP adherence for document exchange, archival, and electronic data integrity.
• Licensing Support
• Coordinating and compiling quality documents required for dossier submissions, renewals and variations
• Ensuring availability and accuracy of GMP/QMS documentation including Site Master File, Stability data, and CPPs.
  
  

Qualifications & Pre-Requisites

Bachelor / Master of Pharmacy / Master of Science

Experience in USFDA, EU, MHRA, WHO regulatory environments and requirements of contract manufacturing operations specifically formulation point of view

Additional notesIt would require frequent travel across CMO's and at Rubicon sites, as on need basis.