Role & responsibilities
- Review and approve Validation, Qualification & CSV documents for equipment, instruments, facilities, and utilities.
- Standardize and harmonize SOPs for Validation, Qualification & CSV across sites in line with regulatory requirements.
- Conduct GMP audits and assess SOP implementation and compliance; identify gaps and ensure effective CAPA implementation.
- Participate in technical reviews and decision-making for Validation, Qualification & CSV issues.
- Assess recent molecules and define validation strategies for process validation, cleaning validation, and hold-time requirements.
Preferred candidate profile
- M.Pharm with 615 years of experience in Pharmaceutical Quality/QA.
- Strong experience in Validation, Qualification & Computerized System Validation (CSV).
- Hands-on knowledge of GMP, regulatory requirements, SOPs, CAPA, and Quality Systems.
- Experience in GMP audits, compliance assessment, and gap identification.
- Strong understanding of Process Validation, Cleaning Validation, and Hold-Time Studies.
- Experience in technical review, risk assessment, and decision-making.
- Candidates with Corporate Quality / multi-site exposure will be preferred.
- Strong communication, analytical, documentation, and stakeholder management skills.
Interested candidates can share their resumes at:
[email protected]
📌 Corporate Quality - CSV (Dombivli)
🏢 Encube Ethicals
📍 Dombivli