Connecting to LinkedIn...

QA Specialist

Contract Type: Permanent
Location: Dublin
Contact Name: Laurentina Kennedy
Contact Email: laurentina@rftgroup.ie

Job Description

Quality Specialist

The Senior 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 (CAPA) recommendations related to products. May assist with compliance audits as required.

ESSENTIAL FUNCTIONS
  • 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 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 /bio pharmaceutical companies with increased level of responsibility.
  • Comprehensive knowledge of cGMP, Aseptic Manufacturing and Quality Assurance experience.
  • Sound awareness and understanding of 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
Follow us on Facebook, Linked-in, Twitter