Validation QA Scientist
5 days ago
Job Title: Validation QA Scientist Reporting To: Validation Supervisor Job Description: Responsible for managing validation activities related to equipment, warehouse facilities, cleaning, water systems, and utility gases, ensuring that the production environment and critical systems comply with GMP and relevant regulatory requirements, thereby guaranteeing product quality and production safety. Key Responsibilities Develop and draft validation plans, protocols, and related documents for equipment, warehouse facilities, cleaning, water systems, and utility gases. Review validation protocols, reports, and related technical documents to ensure compliance with company standards and regulatory requirements. Track and supervise the execution of validation activities, coordinating with relevant departments to ensure smooth completion. Organize and participate in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of equipment. Design and execute cleaning validation protocols, ensuring the effectiveness and reproducibility of cleaning procedures. Participate in validation of water systems and utility gases, ensuring systems meet design specifications and usage standards. Responsible for Computerized System Validation (CSV), including validation planning, risk assessment, test script design, and execution, ensuring compliance with GAMP5 and relevant regulations. Review monitoring data and periodic monitoring reports of cleanrooms and purified water systems. Handle system-related changes and deviations, driving investigations and implementation of corrective and preventive actions (CAPA). Support customer audits by preparing audit documentation and cooperating throughout the audit process. Qualifications Bachelor's degree or above in Pharmacy, Chemistry, Mechanical Engineering, or related disciplines. 1-3 years of experience in validation QA within the pharmaceutical industry. Familiar with GMP, FDA, EU GMP regulations, and validation standards. Proficient in validation processes and requirements for equipment, warehouse facilities, cleaning, water systems, and utility gases. Familiar with Computerized System Validation (CSV) processes and GAMP5 guidelines. Capable of drafting validation plans, protocols, and reports; proficient in Microsoft Office applications. Strong communication and coordination skills, team-oriented, with a strong sense of responsibility. Fluent in both Chinese and English, capable of reading and drafting validation-related documents. #J-18808-Ljbffr
-
Validation QA Specialist: GMP, CSV
5 days ago
Singapore WuXi Chemistry Full timeA pharmaceutical company in Singapore is seeking a Validation QA Scientist responsible for managing validation activities related to equipment and facilities. The ideal candidate holds a Bachelor's degree and has 1-3 years of experience in validation QA. Key responsibilities include drafting validation plans and supporting audits to ensure compliance with...
-
QA Validation Engineer
1 week ago
Singapore No deviation Pte Ltd Full timeAbout Nd Incorporated in 2007, we are a patient-centric solution provider for the pharmaceutical industry. We are experts in engineering consultancy, commissioning, qualification and validation services, and regulatory quality/compliance in Asia and Europe. We offer personalized focused solutions for the pharmaceutical industry in engineering consultancy...
-
Sr QA Validation Engineer
4 days ago
Singapore GDMC Full time**Key **Responsibilities** Your responsibilities include, but are not limited to: - This position will support operational readiness of a new facility. - Establishment of QA Validation procedures (drafting and reviewing QA Validation functional SOPs). - Act as SME to develop commissioning, validation and qualification procedures, train and guide site...
-
Manager, QA System Validation
11 hours ago
Singapore HOYA MEDICAL SINGAPORE PTE. LTD. Full time**HSO way of working** In fulfilling our roles, we are - Accountable for our own capabilities and development. - Focused on delivering results without excuses, and - Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively. We are looking for people who - See beyond self and are impact...
-
QA Validation Engineer
1 week ago
Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time**Position: QA Validation Engineer** At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists. We are currently expanding our team and are looking for a QA Validation...
-
QA/qc Validation Engineer
2 weeks ago
Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full timePosition: QA Validation Engineer At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists. **Job Description**: We are currently expanding our team and are looking for a...
-
QA Specialist
1 week ago
Singapore PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD. Full timePreparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines. - Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility. - Preparation and review...
-
QA Specialist
2 weeks ago
Singapore Pharmagend Global Medical Services Pte Ltd Full timeHRBP at Pharmagend Global Medical Services Pte Ltd Job Summary: The role is responsible for planning, executing, and maintaining validation and qualification activities for equipment, utilities, facilities, processes, and computer systems to ensure compliance with regulatory and GMP standards. Key responsibilities include preparing and reviewing...
-
QA Specialist
5 days ago
Singapore Pharmagend Global Medical Services Pte Ltd Full timeKEY DUTIES AND RESPONSIBILITES: Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines. Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and...
-
On-site QA Scientist
5 days ago
Singapore WuXi Chemistry Full timeJob Title: On-site QA Scientist Reporting To: QA Supervisor Main Responsibilities Conduct on-site inspections of production workshops and warehouses to ensure compliance with GMP and relevant quality standards Review and approve the release of raw materials, ensuring they meet quality requirements before use Review and approve the release of packaging...