Job Description

Industry : Pharmaceutical
Location: Gul Circle
Salary up to $6,500 depending on experience

Job Summary:

• Responsible for the execution and supervision of cGMP-related activities on site to comply with all relevant regulatory requirements of cGMPs, health, safety and environmental standards.

Responsibilities
Site Quality Assurance operations -

• Review and approval of completed manufacturing batch records and related documents prior to assignment of status for a batch.
• Responsible for batch release.
• Review of SOPs/master batch records/ specifications/ laboratory methods and GMP related documents as per GMP requirements and internal guidelines.
• Review and approval of changes that could potentially impact the quality of the product.
• Review and approval of Deviation and Laboratory investigations.
• Monitor progress on corrective actions to assure timely compliance and works with site operation on problem prevention activities and system improvements.
• Perform Quality risk assessment or evaluation.
• Involve in the preparation of Product Quality Review

Site QA Validation expert -

• Participate in projects and ensuring the validation/qualification are execute in conformance with GMP.
• Serves as QA Validation site point of contact and thus review and approval of all validation/qualification documents related to facilities, utilities and equipment and process

Cross-functional team -

• The senior QA Executive is the Quality Representative in the Autonomous Production Team (APU), working closely with teammates from production, engineering, safety and logistics.

Requirements:

• Experience in batch release, deviation and investigation handling. Validation lifecycle, commissioning and qualification/validation (IQ/OQ/PQ), including Computer System Validation (CSV).
• Good communication and organizational skills
• Knowledgeable of analytical chemistry and/or microbiology. Good knowledge of Health Authorities regulations and cGMP
• A degree in Chemistry, pharmacy, microbiology or any other related scientific discipline with minimum of 8 years\' experience in Chemical / Pharma industries

Lim Pey Chyi - Apple.lim@manpower.com.sg
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423

Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579

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