We are seeking a highly skilled professional to join our team at an award-winning organization based in Tipperary. This is an excellent opportunity for anyone looking to work with a leading multinational company that excels in their field.
Duties and Responsibilities:
* Complete auditing and review of batch documentation to ensure compliance with 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, GMPs, and regulatory requirements.
* Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
* Utilize 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 Standard Operating Procedures (SOPs).
* Perform and review complaints and deviation investigations, change controls, and CAPAs.
* Assist in the induction process for new starters and training of other staff.
* Compile data for reports and presentations, provide data interpretation, and draw conclusions.
* Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements.
* Keep abreast of cGMP requirements as described in applicable worldwide regulations.
* Represent the department on cross-functional teams.
* Assist in the generation, review, and approval of Technical & Quality Agreements.
Required Skills and Qualifications:
* Bachelor degree in a Quality, Science, or Engineering discipline, potentially with a higher degree and/or significant industrial experience.
* 3 years of relevant post-degree experience in a GMP environment.
Key Performance Indicators:
1. Audit and review completion rates meet regulatory requirements.
2. Product quality and reliability improved through effective problem-solving and collaboration.
3. New procedures implemented result in increased efficiency and reduced errors.
4. Team performance and engagement enhanced through effective communication and training.
5. Continuous improvement initiatives led to cost savings and enhanced customer satisfaction.