Validation and QA Specialist 1
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 master’s 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.