Quality Assurance Associate
- Tullyvin, Cootehill, County Cavan,
- Permanent | Full Time
- Contact name: Univet
Univet is a family owned business based in Ireland that since our inception have succeeded in manufacturing, registering and marketing a diverse range of products to provide for our farming customers and we have a position for a Quality Assurance Associate.
The Quality associate is responsible to ensure International quality and compliance requirements are fulfilled for the supply of products in accordance with international and domestic requirements. As the QA associate, will maintain a Quality Management System and lead Quality Reviews . The incumbent will plan, coordinate, manage and /or facilitate external audits/inspections and provides leadership during regulatory inspections.
This position is to implement and execute tasks relating to QA duties and certification activities associated with manufacturing processes/activities performed under Univet’s MA and veterinary licences.
- To provide support as required to the Quality Director and QPs in all matters relating to the provision of technical delivery of client projects.
- To manage and to deliver QA activities relating to delivery of client projects and to maintenance of the Quality Management System (QMS).
- Maintain compliance with GMP and FDA and customer audits as defined in quality agreements, HPRA/Ireland legal frameworks, HPRA licences and EU GMP directives/Guidelines.
- Provide advice to Univet staff and customers regarding QA requirements to ensure compliance to GMP and FDA.
- Manage the process that develops, establishes, and maintains quality assurance programs, policies, process, procedures and controls ensuring that performance and quality of both drug substance and drug product are in accordance with Good Manufacturing Practices requirements.
- Participate in internal compliance audits and respond to audit observations.
- Lead/Host regulatory/customer inspections and respond to inspection observations as needed.
- Leads inspection/audit readiness activities and communicating progress and opportunities with the senior site leadership.
- Responsible for keeping “Audit Readiness Scorecard” and reviewing with site leadership
- To manage all elements of the QMS including but not limited to:
- Change Control
- Customer Complaints
- Review and approval QMS documents, including but not limited to the following:
- Failure investigations
- Change controls
- Corrective/preventative action documents
- Standard operating procedures
- To aid in the installation and transfer of the above to an electronic database and other records as required : Change Control and Deviation Management.
- To manage preparation of batch files and issues arising to facilitate batch release in a timely manner to meet client requirements.
- To provide monitoring and trending metrics associated with the QMS and current operating systems.
- To support and participate in regulatory and customer audits as required.
- To collaborate with contract parties to resolve issues and maintain compliance.
- To manage and participate in internal audits as per the annual audit plan.
- To manage and drive supplier qualification activities ensuring Approved Supplier Lists are maintained.
- To co-ordinate and manage Product Quality Reviews.
- To identify gaps in systems and to support system improvements as required.
- Thorough knowledge of cGMPs/cGDPs for APIs and medicinal products requirements.
- 3rd Level Qualification in Science or Quality Management
- High level Computer Literacy and competency – Microsoft Office, Microsoft Project.
- This role requires a minimum of 5 years experience in, Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry.
- A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
- Must be proficient at technical and understand of quality processes associated with quality, CAPA, deviations/exceptions, root cause analysis, change control and quality concepts in a distribution center/commercial office environment.
- This role is expected to be “hands on” and “working” manager.
- Experience working in regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11
- Good interpersonal skills, ability to interact with cross-functional teams and internal/external stakeholders.
- Good written communication skills/numeracy/literacy.
- Good team-working skills with ability to direct and influence team members.
- Experience in batch record review and review of batch related documentation.
- Technical experience in aseptic processing or manufacturing operations.
WHAT WE OFFER
At Univet, you can have a good job that can grow into a great career. We offer:
- Training and career development, with on-boarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- Retirement savings
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities