Quality Assurance Specialist

Your Role

Quality Assurance Specialist is to promote and integrate quality into every aspect of our BioReliance biologics safety testing business in Singapore. The role is to perform batch record review (i.e. data audits) to support all aspects of quality operations to ensure that laboratory testing operates in full compliance with sound scientific practice, GxP and Standard Operating Procedures (SOPs).  The scope of responsibility is to contribute or impact the results of the QA team and is accountable for the quality of own work, solve problems of low complexity independently by identifying and selection solutions and by analyzing information.

The post holder will be able to perform the following functions independently, with minimal guidance.

What You Do

• Batch record review:Review and approval of GxP documents, including Protocols, Technical Specification (TS), Batch Records, Workbooks, SOPs and all other QMS documentation.
• Batch record review:Comply with all applicable policies, procedures and guidelines.
• Batch record review:Conduct in-process or final audits and approval on manufacturing or testing documentation as they comply with the stated regulatory standards and the approved TS, protocol or SOPs.
• Batch record review:Release of the certificate of analysis for GMP testing against the TS and associated documentation.
• Batch record review:Prepare QA statement within each GLP final report specifying inspections date, and dates findings were reported to the Study Director and management.
• Review and approve deviations, anomalous results, OOS, positive results and CAPAs.
• Assist in investigations from events, complaints or data audits.
• Conduct trend analysis for deviations and review / approve applicable CAPA records.
• Assist self-inspections to ensure continuous improvement.
• Perform and support client audits, regulatory inspections.
• Perform and support internal audits.
• Perform and support supplier audits.
• Comply with Health and Safety Executive regulations and undergo relevant training modules when required and actively takes necessary action when encountering unsafe situations.
• Perform their duties according to the principles of Good Laboratory (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).

The above list of job duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post. 

Who You Are

• Graduate degree in life sciences or higher related degree
• Minimum of 2 – 4 years of experience, within a similar Quality Assurance role i.e. batch record review.
• Shows a desire and motivation to work in Quality and regulated environment.
• Awareness of Biologics regulatory environment and GMP manufacturing topics.
• A proactive approach to all aspects of Quality.
• Fluent in both written and spoken English.
• Good communicator, dealing directly and effectively with operational teams and site QA and lab colleagues routinely.
• Strong analytical and problem solving abilities.
• Organized and logical in defining workload and delivering projects.

Core Competencies:

• Technical and problem solving skills
• Has the functional and technical knowledge and skills to do the job
• Can learn new skills and knowledge quickly
• Uses logic to solve problems with effective solutions
• Makes good decision
• Energy and Drive
• Self-motivating; is action-oriented and full of energy for the things he / she sees challenging
• Pursues everything with energy, drive and the need to finish, especially in the face of resistance and setbacks
• Can be counted on to achieve goals, constantly and consistently, pushes self and others for results
• Professional and interpersonal skills
• Relates well to all kinds of people in the organization, builds constructive and effective relationships using diplomacy and tact
• Is seen as a team player, cooperative, easily gains support of peers, encourages collaboration

Additional Local Needs:

• Global mindset and to be willing to engage in conference calls at out-of-office hours.