MANAGER / SPECIALIST -VALIDATION

Experience :  10+ years in pharma validation (FMCG less preferred) across one or more areas – CSV (Mandatory), Equipment / Utility Qualification, or Process / Cleaning / Method Validation.

Focus Areas :

CSV :  Strong knowledge of FDA, GAMP 5, and global regulations (US, EU, TGA; Japan a plus)

Equipment / Utility Qualification :  Installation / operational / performance qualification, risk assessment, CAPA

Process / Cleaning / Method Validation :  Oral solid, topical, spray forms preferred

Responsibilities :

Lead and manage validation projects across global sites, develop SOPs and standards, ensure compliance (cGMP, ISO, WHO), perform risk and gap analyses, support audits and CAPA, and mentor site teams via COP forums.

Ideal Profile :

Strong in CSV plus complementary experience in equipment / utility; capable of designing validation strategies and managing cross-functional teams.

Salary Budget - 8-11 LPA

Skills Required

Fda, Csv, Risk Assessment, Capa