Assistant Manager – Qualification & Validation (OSD)

Acme Formulation; Solan; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Acme Formulation in Solan, Himachal Pradesh, seeks an experienced Senior Validation & Qualification Specialist to lead equipment qualification, process and cleaning validation, and related regulatory deliverables.

You will prepare and maintain VMP, validation protocols, reports, and SOPs, ensure timely qualification of facilities and utilities, support audits, and coordinate with QA, Regulatory Affairs and Manufacturing to ensure data integrity and cGMP compliance across USFDA/EU GMP/WHO GMP

Qualifications

• Requires B.Pharm / M.Pharm / M.Sc. with 8-12 years in Qualification & Validation in a regulated OSD pharma facility.

Responsibilities

• Execute and review Equipment Qualification (DQ/IQ/OQ/PQ) for manufacturing, packing, utilities, and laboratory equipment.
• Plan, execute, and review Process Validation, Cleaning Validation, Hold Time Validation, and Revalidation activities.
• Prepare and maintain Validation Master Plan (VMP), validation protocols, reports, and related SOPs.
• Ensure timely qualification of facilities, utilities (HVAC, Water System, Compressed Air), and equipment.
• Review validation-related deviations, change controls, CAPA, and risk assessments.
• Ensure compliance with cGMP, data integrity, and regulatory requirements (USFDA, EU GMP, WHO GMP).
• Support internal, customer, and regulatory audits.
• Coordinate with Production, Engineering, QC, Warehouse, and Regulatory Affairs for validation activities.
• Support APQR/PQR, technology transfer, and qualification documentation for regulatory submissions.
• Conduct validation-related training and ensure documentation compliance.

Skills

Equipment Qualification

Process Validation

Regulatory Compliance

Data Integrity

Audit Readiness

Education

B.Pharm / M.Pharm / M.Sc.

Job description

• Execute and review Equipment Qualification (DQ/IQ/OQ/PQ) for manufacturing, packing, utilities, and laboratory equipment.
• Plan, execute, and review Process Validation, Cleaning Validation, Hold Time Validation, and Revalidation activities.
• Prepare and maintain Validation Master Plan (VMP), validation protocols, reports, and related SOPs.
• Ensure timely qualification of facilities, utilities (HVAC, Water System, Compressed Air), and equipment.
• Review validation-related deviations, change controls, CAPA, and risk assessments.
• Ensure compliance with cGMP, data integrity, and regulatory requirements (USFDA, EU GMP, WHO GMP).
• Support internal, customer, and regulatory audits.
• Coordinate with Production, Engineering, QC, Warehouse, and Regulatory Affairs for validation activities.
• Support APQR/PQR, technology transfer, and qualification documentation for regulatory submissions.
• Conduct validation-related training and ensure documentation compliance.

Qualification

• B.Pharm / M.Pharm / M.Sc.

Experience

• 8-12 years of Qualification & Validation experience in a regulated OSD pharmaceutical manufacturing facility.