Assistant Manager Validation

About the role

The Assistant Manager Validation supports the Senior Validation Manager and the Validation Review Board (VRB) in executing validation and qualification activities across products, processes, equipment, utilities, and facilities. This role ensures compliance with regulatory standards and internal policies while driving continuous improvement.

Key responsibilities

• Implement and enforce SOPs, EQD/AQR policies, and validation/qualification procedures.
• Develop, review, and execute cleaning validation protocols (IQ/OQ/PQ) and establish acceptance criteria for residues and microbial contamination.
• Perform risk assessments, coordinate sample collection, and oversee analytical testing (TOC, HPLC, swab/rinse).
• Prepare validation reports, maintain the Cleaning Validation Master Plan, and support equipment, utility, CIP/SIP qualification.
• Investigate deviations, trends, and failures; implement CAPAs and support audit activities as the cleaning validation SME.
• Manage computer system validation (CSV) deliverables, conduct 21 CFR Part 11/Annex 11 assessments, and oversee system lifecycle documentation.
• Collaborate with Operations, Engineering, QA, QC, IT, and vendors on system upgrades and regulatory inspections.

Required profile

• Science graduate (BSc/MSc) preferably in Chemistry, Microbiology, or Pharmacy.
• 4‑5 years of experience in validation/qualification within a regulated environment.
• Strong knowledge of cGMP, FDA, EU EMA, ICH Q7, and related regulatory requirements.

Required skills

• Cleaning Validation and IQ/OQ/PQ protocol development
• Analytical techniques: HPLC, TOC, swab/rinse analysis
• Risk assessment and CAPA implementation
• Regulatory compliance: cGMP, FDA, EU EMA, ICH Q7
• 21 CFR Part 11 & Annex 11 compliance
• Computer System Validation (CSV) and system lifecycle management
• User access management, change control, audit‑trail management
• Cybersecurity controls and backup/restore testing

What we offer

• Opportunity to work in a highly regulated, innovative environment.
• Collaboration with cross‑functional teams and exposure to global regulatory standards.