We have an exciting new opportunity for a QA Specialist with a well know multinational client of ours in the region.
JOB PURPOSE:
To act as Quality Assurance representative to ensure that the plant is operating to cGMP requirements and that processing is in compliance with regulatory filings. To liaise with the all site functions as necessary to resolve quality issues and perform batch review to permit product release.
PRINCIPAL ACCOUNTABILITIES:
• Review manufacturing records for completeness and cGMP compliance to support the release process as necessary.
• Review and approve plant manufacturing instructions to ensure conformity with site standards and regulatory processes
• Evaluate site procedures on an on-going basis to ensure compliance. Review and approve procedures in Mikado system as necessary. Prepare SOP updates as requested by quality management ensuring where appropriate that global approach is reflected.
• Support site deviation management and CAPA systems as part of the QA team
• Provide training, support and advice to colleagues on-site to facilitate cGMP improvement and best practice.
• Interact with other functions on site, particularly Operations, Supply Chain, Engineering, QC and Technical Services to ensure that quality and site goals are achieved
• Participate in site initiatives such as Continuous Improvement projects to promote improvement activities and achieve quality goals.
• Support the QP in relation to all batch release activity, primarily performing QA review of batch documents, including records originating from external parties.
• Liaise with external parties on resolution of issues relating to document errors to support release.
• Act as QA contact (in conjunction with site QP) and deputise on behalf of QP where appropriate for drug product related quality issues and associated communications.
• Act as a QA contact with other departments and external parties to support the drug product release process and supply of post release documents.
• Maintain and report Metrics relating to batch release activities.
QUALIFICATIONS:
• A degree in chemistry or another relevant science subject or several years’ relevant experience in the pharmaceutical industry.
SKILLS:
• Organisational and time management skills (is organised and can prioritise demands).
• Good communication skills: listening, written, verbal and interpersonal (ability to communicate effectively at all levels and with varying personalities).
• Good attention to detail, high level of accuracy in all aspects of the position.
• Good problem solving abilities.
• Self-starter, positive attitude and motivated by the role.
• Good work ethic and ability to meet assigned deadlines.
• Flexible and willingness to adapt with business requirements.
• Works to the highest professional, ethical and moral standards.
EXPERIENCE:
• Preferably experience in quality assurance function, experience working in a multinational, regulated environment a distinct advantage
KNOWLEDGE:
• Good working knowledge of cGMP , especially Quality Systems
• Good level com
