Corporate Quality - CSV

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 new 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]