The Quality Specialist will be capable of working on complex issues where analysis requires an in-depth assessment, considering many variables and potential consequences. May conduct or serve as a lead/coordinator of investigations and corrective and preventive action recommendations related to products. May assist with compliance audits as required.
- Responsible for Quality oversight, with management support of external manufacturing, warehousing operations, validation, verification and quality control of combination product(s) (devices).
- Perform batch documentation review, management of changes, complaints, deviations, validations and product annual reviews to ensure completeness, accuracy and compliance.
- Co-ordinate with CMO Quality and Operations teams to independently resolve discrepancies while liaising with internal Quality Groups to ensure on-time disposition of Finished Product.
- Evaluation and approval of supplier and CMO change notifications. Author and coordinate applicable changes through the Change Management process as required.
- Author, review and approve Quality-Related Procedures as required in accordance with
- internal procedures and GMP principles to ensure quality objectives are met.
- Active participation and support implementation of continuous improvement initiatives of the Device Quality Business Unit.
- Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor the progress of follow up actions.
- Support the stability program for combination products (devices) as required, facilitating communication and data acquisition between supply chain, contract manufacturers and stability program coordinator.
- Support the Vendor and Raw Material Qualification Program through collaboration with SQM Group To facilitate discussions between CMO Quality organizations to establish responsibilities for Quality related functions.
- Provide Quality support for technology transfer across contract organizations to include validation/verification activities and Laboratory Investigation Report review and approval for commercial and developing product pipelines.
- Support regulatory department with any regulatory filings associated with new market authorisations, annual reports and change supplements.
- Responsible for identifying defects and have the authority to report device defects at any time.
EDUCATION, EXPERIENCE, SKILLS
- Academic degree in Engineering or Science (preferably in an Applied Science).
- Minimum 6 years’ experience working in international device and pharmaceutical /biopharmaceutical companies with an increased level of responsibility.
- Comprehensive knowledge of cGMP, Aseptic Manufacturing and Quality Assurance experience.
- Sound awareness and understanding of the pharmaceutical business, especially with regards to quality and regulatory requirements.
- Demonstrates thorough knowledge of FDA / EMEA standards and quality systems. Having interface with or participating in regulatory agency inspections preferred.
- Ability to deliver in a challenging environment using own initiative with little instruction on routine work, general instructions on new assignments.
- Strong mature leadership and interpersonal influencing skills showing personal/departmental accountability and responsibility.
- Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
- Ability to operate efficiently in a complex matrix organization and international environment making sound decisions regarding compliance-related issues with minimal supervision.
For further information on this QA Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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