The Associate Director of QA will be responsible for performing key Quality tasks in respect of Company products and development projects. Work in the Quality Group, within the Technical Operations department, which oversees contract manufacturing operations, select supply chain operations and development functions as well as internal Quality Systems.
Reports directly to the Director Quality Assurance.
The Associate Director Quality Assurance is responsible for monitoring and supporting the quality performance of contract manufacturers, distributors and material suppliers to all applicable standards for GMP and GDP. This individual will receive assignments in the form of goals.
- Managing product quality related priorities and tasks at the respective contract manufacturers
- Leading and monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, change controls and leading product related investigations
- Designing, Implementing and improving quality systems to realize the highest quality standards attainable for all activities conducted by the company, supporting Product Quality Review and annual report completion on time and leading training
- Facilitating technology transfer, process scale-up and process improvement protects
- Building authentic relationships and leading business meetings and audits of critical suppliers and contract manufacturers and maintaining all product related Technical Quality Agreements (TQAs)
- Assisting in internal audits and regulatory agency inspections
- Ensure compliance of all respective contract manufacturers to both internal requirements and country specific regulations
- Highlight any risks associated with maintaining supply of commercial drug products to all markets and offer innovative and effective ways to minimise such risks,
- Collaborate with all contract manufacturers, packagers and testing laboratories to resolve any quality issues and guarantee an uninterrupted supply of drug product to the markets.
- Contribute to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, packagers and laboratories, as required.
- Maintain quality and regulatory compliance, to ensure that there are no significant regulatory agency citations associated with any company specific GMP activities. In this respect, it may be necessary to collaborate with the regulatory affairs department and liaise with regulatory agencies in the process of resolving GMP specific quality issues.
- Evaluate proposed changes to the manufacturing and supply chain processes, and authorise these changes, if appropriate.
- Contribute to management of the supplier approval programme and to maintenance of the external audit schedule.
- Understand new regulations and guidelines, as they apply to the company business, and implement systems and procedures to incorporate these new regulations, if appropriate. Communicate, where appropriate, with the Corporate Compliance group, on areas of common interest.
- Communicate, where appropriate, with all corporate personnel and contribute to the development of global systems and procedures, as required.
- Contribute to the design and implementation of best practice quality improvement programmes and company expansion programmes.
- Contribute to the development of quality policies and procedures and participate in the internal audit programme, which serves to verify adherence to and compliance with the requirements set out in these controlled documents.
- Contribute, as required, to the development of new drugs, which will deliver a robust product pipeline without significant delays in the regulatory approval process.
- A BSc or Masters level in a science discipline is required, with an excellent understanding of quality assurance. Qualified person status and experience preferred but not essential. A strong understanding of, and experience in quality management is essential.
- At least 7 years' experience gained in finished product pharmaceutical manufacturing is required.
- Knowledge of QA for all pharmaceutical dosage forms and drug substance manufacture is desirable.
- An excellent understanding of quality guidelines and regulatory requirements as they apply to the industry is required.
- Customer orientated with excellent communication skills and the ability to apply pragmatic logic to problem solving and issue resolution is also required.
For further information on this Associate Director of Quality Assurance position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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