QA Validation Lead - BioPharma
EFOR (formerly Process Engineering Specialists)
Singapore · À temps plein
Soyez le premier à postuler
- Expérience
- N'importe lequel
- Salaire
- —
- Ouvertures
- 1
- Publié
- il y a 8 heures
- Mode de travail
- Au bureau
- CV
- Candidature requise
Votre lieu de travail
Description de l'emploi
About the Company
EFOR, previously known as Process Engineering Specialists (PES), provides international excellence in Project Management, Construction Management, Commissioning & Qualification, and Automation services primarily for pharmaceutical, nutritional, and related sectors. Operating with offices throughout Europe, Asia, and the US, EFOR emphasizes delivering consistently high-quality results spanning more than 20 years.
Job Overview
The role involves leading quality assurance oversight for validation and qualification efforts in manufacturing, utilities, facilities, equipment, and computerized systems within the life sciences sector. This is a permanent, on-site position based in Singapore.
Key Responsibilities
- Lead QA oversight for validation activities including manufacturing, utilities, equipment, and computer systems.
- Review and approve validation protocols, reports, and related documentation ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory standards.
- Provide quality assurance for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Validation, Cleaning Validation, and Computer System Validation (CSV).
- Evaluate and authorize deviations, investigations, CAPAs, and change controls related to validation.
- Ensure adherence to the company's Quality Management System (QMS), Data Integrity policies, and Good Documentation Practices (GDP) throughout validation activities.
- Collaborate with Engineering, Manufacturing, Manufacturing Science and Technology (MSAT), Quality Control, and other cross-department teams for project support and product lifecycle management.
- Support regulatory inspections and client audits by providing quality expertise and the necessary validation documentation.
- Identify compliance risks and initiate continuous improvements to strengthen validation and quality processes.
- Mentor and guide validation and quality teams on GMP and industry best practices.
- Stay updated with global regulatory requirements and industry guidelines to ensure ongoing compliance and readiness for inspections.
Additional Information
EFOR embraces equal employment opportunities without discrimination based on age, race, religion, sexual orientation, or other unrelated factors. The company welcomes candidates from diverse backgrounds.