Job Description

• 5 Days [ 8:30am -6:00pm]
• Near Kent Ridge and Queenstown
• Quality Management / Biotechnology / Pharmaceutical / Consumer Healthcare / ISO 15189 / 13485 / GCP / GMP / GLP
• Life Science / Pharmacy / QA/ QC / HSA / MOH / US

Interested applicants can send your resume to WhatsApp: +65 90814261 and allow our Consultants to match you with our Clients. No Charges will be incurred by Candidates for any service rendered.

Requirements:

• Bachelor's or Master's degree in Life Science/Pharmacy, or equivalent combination of education and experience.
• At least 3 years' experience in a quality management, QA/QC role within pharma or life sciences related industry.
• Experience in devising and establishing a company's quality procedures, standards and specifications.
• Good knowledge of quality management standards and production management (e.g. ISO 15189 / 13485, GCP, GMP, GLP).
• Hands on experience liaising with the HSA/MOH/US FDA etc and various other regulators preferred.
• Working knowledge in Singapore regulations (e.g. Human Biomedical Research Act, Healthcare Services Act, Medical Device registration etc) and/or other regional regulations for in-vitro diagnostics or medical devices will be an advantage.

Responsibilities:

• A Quality Management Manager is required to lead and drive compliance to all quality processes and procedures developed for in-vitro and in-vivo preclinical services and products, clinical services and consumables business units. This position will report to General Manager, Singapore.
• Be responsible for the establishment and maintenance of a quality management system for in-vitro and in-vivo preclinical services and products, and Onco-PDO clinical services business unit.
• Set requirements for all products and service assays based on prevailing industry standards and regulations and monitor for compliance.
• Initiate the development of specific quality procedures and SOP's by engaging Process Owners and internal Approvers. Maintain full sets of quality procedures and SOP's and implement regular updates to these documents.
• Develop internal quality management tools to regularly assess all product and assay development procedures to identify deviations from quality standards and implement corrective action plans.
• Plan and conduct internal audits of all business units, provide recommendations and training for process improvement.
• Investigate causes of quality problems, propose solutions and engage all key stakeholders in implementation.
• Take appropriate actions in championing and developing the culture of quality improvement and awareness.
• Initiate and implement improvements to production processes that lead to overall increases in product and service quality, and process efficiency.
• Work together with Department Heads and Project Leaders to discuss solutions to quality issues.
• Create production plans for new products to guarantee quality from stage one.
• Solicit feedback from customers to assess whether their requirements are being met.
• Plan, develop and support the training of employees in Quality Management and Quality Control processes and procedures.
• Provide continuous education on newly developed Quality Control techniques.
• Act as liaison person for any external audits or inspections by regulatory authorities or Clients. Lead the audit process from preparation, attendance, follow up to close-out.
• Provide regular report of Quality Management activities and performance.
• May represent company at professional meetings, seminars or conferences. Performs otherwork-related duties as assigned.

Additional Information

Career Level

Manager

Qualification

Professional Certificate/NiTEC, Diploma, Advanced/Higher/Graduate Diploma

Years of Experience

1 year

Job Type

Full-Time

Job Specializations

,

Company Overview

Here at The Supreme HR Advisory, we pride ourselves on being a vibrant recruitment firm with strong Southeast Asia standing. We believe in customizing our services to your unique needs. We are dedicated, enthusiastic and we take innovative approaches in customizing our services. Our depth of experience enables us to understand each industry's challenges and provide expert advice on hiring requirements. Our goal is to leverage on our local knowledge and global expertise to deliver high-quality candidates specifically matched to the requirements of each of our client.

Additional Company Information

Registration No.

201426535W

EA No.

14C7279

Company Size

51 - 200 Employees

Average Processing Time

15 days

Industry

Human Resources Management / Consulting