Validation and QA Specialist

Randstad; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Randstad seeks a senior validation professional to define and oversee validation across equipment, facilities, and utilities within a cGMP greenfield site in Bengaluru. You will own IQ/OQ/PQ lifecycle management, risk assessments (FMEA) and regulatory alignment under GAMP 5, FDA 21 CFR Part 11 and ISO 9001.

You will lead audits, CAPAs, and cross-functional collaborations, ensuring timely remediation and data-driven decision making.

Qualifications

• Hands-on experience in IQ/OQ/PQ protocols across equipment, systems, facilities and utilities.
• FMEA and impact assessments; risk-based validation decisions.
• Knowledge of cGMP, GAMP 5, FDA 21 CFR Part 11 and ISO 9001.

Responsibilities

• Identify, plan, and implement validation requirements across equipment, instruments, utilities, and manufacturing/testing processes in a cGMP greenfield facility.
• Prepare, execute, and manage IQ/OQ/PQ protocols across equipment and facilities in a cGMP environment.
• Coordinate and support cleanroom qualification and utility qualification activities; govern the Validation Master Plan and validate/approve documentation.

Skills

IQ/OQ/PQ

FMEA

GAMP5

FDA CFR Part 11

ISO 9001

HVAC principles

QMS

Regulatory awareness

Cross-functional leadership

Analytical thinking

Education

Degree in Biotechnology/Engineering or Masters in Pharmaceuticals

Job description

Your Role:

• Identify, plan, and implement validation requirements across equipment, instruments, utilities, and manufacturing/testing processes in a cGMP greenfield facility.
• Demonstrated hands‑on experience in preparing, executing, and managing IQ/OQ/PQ protocols across equipment, systems, facilities, utilities, and manufacturing or testing processes in a cGMP environment.
• Coordinate and support cleanroom qualification, facility and utility qualification activities; create and govern the Validation Master Plan (VMP); review, approve, and maintain validation protocols, SOPs, and technical documentation in a controlled, compliant manner (cGMP, GAMP 5, FDA 21 CFR Part 11, ISO 9001).
• Identify and assess validation changes, deviations, and CAPAs; ensure remediation and closure of compliance actions; conduct risk assessments (FMEA, impact assessments); perform trend analysis of non‑conformances and data reviews; ensure QMS conforms to ISO 9001 and organizational policies; lead audits and regulatory inspections; drive root cause analysis and timely closure of corrective actions; collaborate with cross‑functional teams to drive validation deliverables.
• Acts as the site validation owner, quality face to customers; performs process audits to identify gaps and implement corrective actions; supports technology transfer and global projects; stays current with industry regulations and trends; supports EHS/OSHA as required; operates in a multi‑cultural, multi‑time‑zone environment; demonstrates strong networking and problem‑solving skills to influence across organizational levels.
• Strategic objective: build a strong Validation Team to enable successful product transfers; works closely with Production, Maintenance, and cross‑functional teams; engages with suppliers and service providers.
• Candidates must have direct implementation experience and ownership of validation activities.

Who You Are:

• Education: Degree in Biotechnology/Engineering or masters degree pharmaceuticals.
• Experience: Minimum 6 years’ total experience, with at least 5 years in a validation role; experience in reputed pharma industries or research institutes; prior involvement in projects, facilities startups, and technology transfer preferred.
• Deep knowledge of IQ/OQ/PQ lifecycle; proficiency in FMEA and impact assessment; understanding HVAC principles; strong problem‑solving, analytical, and communication skills; ability to lead change and build cross‑functional relation.
• Communication and collaboration skills will be evaluated as key selection criteria alongside technical expertise, including the ability to influence cross‑functional teams, lead discussions, and drive timely resolution of validation‑related issues.