6075
puestos de Regulatory Affairs en United States
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Quiero recibir las últimas vacantes disponibles de puestos de “Regulatory Affairs”
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Automation C&Q (Commissioning & Qualification) Lead
Sé de los primeros solicitantes.
TG Group Pte Ltd
Singapur
SGD 80.000 - 120.000
Sé de los primeros solicitantes.
Hace 2 días
Descripción del empleo
Key Responsibilities:
Required Qualifications & Skills:
To Apply, please kindly email your updated resume to weizhe.teoh@tg-hr.com
Regret to inform that only shortlisted candidates will be notified.
CEI: R25127749
EA License: 14C7275
- Lead the commissioning and qualification (C&Q) activities for automation systems, ensuring compliance with GMP, GAMP, and FDA guidelines.
- Develop and execute C&Q protocols for automation systems, including Distributed Control Systems (DCS), PLCs
- Collaborate with engineering, validation, and quality assurance teams to ensure seamless integration of automation systems.
- Oversee testing, debugging, and validation of automation software and hardware.
- Ensure data integrity and regulatory compliance in automation processes.
- Provide technical leadership and mentorship to junior engineers and technicians.
- Manage documentation related to automation qualification, including URS, FAT, SAT, IQ, OQ, and PQ reports.
- Coordinate with vendors and contractors for installation, commissioning, and troubleshooting of automation equipment.
- Stay updated on emerging automation technologies and regulatory changes in pharmaceutical manufacturing.
Required Qualifications & Skills:
- Bachelor's degree in Electrical Engineering, Automation Engineering, or a related field.
- 12+ years of experience in automation engineering, preferably in pharmaceutical manufacturing.
- Strong expertise in DCS (DeltaV, PCS7), SCADA, PLCs, and MES systems.
- In-depth knowledge of GMP, GAMP 5, FDA 21 CFR Part 11 compliance.
- Experience in commissioning and qualification of automation systems.
- Excellent problem-solving and analytical skills.
- Strong communication and leadership abilities.
- Ability to work in cross-functional teams and manage multiple stakeholders.
To Apply, please kindly email your updated resume to weizhe.teoh@tg-hr.com
Regret to inform that only shortlisted candidates will be notified.
CEI: R25127749
EA License: 14C7275
* El índice de referencia salarialse calcula en base a los salarios que ofrecen los líderes de mercado en los correspondientes sectores. Su función es guiar a los miembros Prémium a la hora de evaluar las distintas ofertas disponibles y de negociar el sueldo. El índice de referencia no es el salario indicado directamente por la empresa en particular, que podría ser muy superior o inferior.
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