QA (Cleaning Validation)

Maya Biotech; Solan; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Maya Biotech is seeking an Executive / Assistant Manager QA (Cleaning Validation) to lead cleaning validation activities for injectable manufacturing under GMP compliance. The role covers planning, execution, review, and regulatory alignment.

Ideal candidates have 6–10 years in QA/Cleaning Validation, with a B.Pharm/M.Pharm/B.Sc/M.Sc or equivalent. Collaboration with cross-functional teams and audits are key aspects of the position.

Qualifications

• 6–10 years of QA/cleaning validation experience.
• B.Pharm, M.Pharm, B.Sc or M.Sc or equivalent.
• Experience in injectable manufacturing is desirable.

Responsibilities

• Plan and review cleaning validation protocols, reports, SOPs, and risk assessments.
• Coordinate cleaning validation activities for equipment, product-contact parts, and areas.
• Review sampling plans, swab/rinse results, and acceptance criteria.
• Ensure GMP, SOPs, validation procedures, and regulatory compliance.
• Manage deviations, investigations, CAPA, and change controls.
• Collaborate with Production, QC, Engineering and Validation teams.
• Support regulatory and customer audits and close observations.
• Maintain cleaning validation docs and periodic review/revalidation.
• Identify opportunities to improve cleaning processes and validation practices.

Skills

Cleaning Validation

QA GMP

Risk Assessment

Protocol/Report Prep

Swab & Rinse Sampling

Deviation/CAPA

Change Control

Audit Compliance

Injectable Manufacturing

Education

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

Job description

Position: Executive / Assistant Manager QA (Cleaning Validation)
Department: Quality Assurance
Industry: Pharmaceutical – Injectable
Experience: 6–10 years in QA / Cleaning Validation

Job Purpose

Responsible for planning, execution, review, and compliance of cleaning validation activities for injectable manufacturing facilities in accordance with GMP and regulatory requirements.

Key Responsibilities

• Prepare and review Cleaning Validation protocols, reports, SOPs, and risk assessments.
• Coordinate and monitor cleaning validation activities for manufacturing equipment, product-contact parts, and production areas.
• Review sampling plans, swab/rinse sampling, analytical results, and acceptance criteria.
• Ensure compliance with GMP, SOPs, validation procedures, and regulatory requirements.
• Manage cleaning validation deviations, investigations, CAPA, and change controls.
• Coordinate with Production, QC, Engineering, and Validation teams for execution of validation activities.
• Support regulatory/customer audits and ensure timely closure of observations.
• Maintain cleaning validation documentation and periodic review/revalidation requirements.
• Identify opportunities for improving cleaning processes and validation practices.

Qualification

B.Pharm / M.Pharm / B.Sc / M.Sc or relevant qualification.

Key Skills

Cleaning Validation QA GMP Risk Assessment Protocol/Report Preparation Swab & Rinse Sampling Deviation/CAPA Change Control Audit Compliance Injectable Manufacturing