CLIENT : An end-to-end solution provider for API Process Development for NCEs and Peptides with presence in over 80 countries.

Position Summary

Ensure that all development activities (e.g., Process development, analytical methods, tech transfer) are conducted in compliance with quality and regulatory requirements across the early and late stages of Active Pharmaceutical Ingredient (API) development.

KEY DELIVERABLES

- Handling and evaluation of QMS activities (incidents, change controls, deviations, Internal audits, etc.).
- Ensure documentation complies with data integrity and compliance with ALCOA+ principles.
- Review of Process development (Development report, risk assessment, Spec. justification etc..) and analytical documents (development reports, spec and MOA and method validation documents).
- Review of Vendor qualification documents
- Ensure effective root cause analysis (RCA) and CAPA for investigations (OOS/OOT/Incidents/deviations).
- Handling of phase gate and Tech. transfer activities.
- Collaborate on resolving any gaps or issues identified during the technology transfer process.




- Oversee DQA requirements during scale-up and technology transfer to manufacturing.
- Foster a culture of compliance, ownership, and continuous improvement.
- Handling of customer calls related to CMS projects and ensuring address of all customers related queries within the timeline.
- Participating in the teleconferences to clarify the customer queries.
- Coordination with Cross-functional teams to meet the project timelines

Incumbent profile:
- Master’s degree in chemistry/Analytical chemistry.
- Experience in CMS projects development: proficient in handling customers of regulated markets, responding to technical and quality-related queries.
- Experience in Generic Drug substance development.
- Knowledge of ICH guidelines and USP general chapters.
- Handling of QMS.
- Practical knowledge of QBD

Annual Compensation: 12-15LPA

Queries

Anoop Sinha-CEO, PROFILE HR CONSULTANTS PVT LTD [email protected]

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📌 Deputy Manager API R&D Quality Assurance (Hyderabad)
🏢 Profile HR Consultants
📍 Hyderabad