Quality Specialist

3 weeks ago

Tamworth, New South Wales, Australia Tandem Project Management Ltd. Full time
Summary:
A Quality Specialist is required for a global pharmaceutical company in South Tipperary. The incumbent will support the review of batch documentation to ensure compliance to SOPs, GMPs and applicable regulations.

Responsibilities:

- Complete auditing/ review of batch documentation to ensure compliance to SOPs, GMPs and applicable regulations.
- Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
- Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
- Utilise this network to help resolve comments and issues that arise during audit and review.
- Manage product recalls and stock recoveries as appropriate.
- Identify compliance gaps and make recommendations for continuous improvement.
- Create and maintain assigned SOPs.
- Perform and review complaints and deviation investigations, change controls and CAPA's.
- Assist in the induction process for new starters and training of other staff.
- Compile data for reports and presentations, provide data interpretation, draw conclusions.
- Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
- Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
- Represents department on cross functional teams.
- Assist in the generation, review and approval of Technical & Quality Agreements.
- Additional activities as assigned by the manager/supervisor.

Qualifications & Experience:

- Degree in a Quality, Science or Engineering discipline and potentially a higher degree and/or significant industrial experience.
- 3+years of industrial experience.
- Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations.
- Effective communications (oral/written) and interpersonal skills are necessary.

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