|Contact Name:||Laurentina Kennedy|
The QA specialist is a key member of the team tasked with successful day-to-day implementation of the Quality Management System (QMS) for the facility as well as supporting other organisational objectives.
The QA Specialist will be responsible for operational and compliance support for manufacturing operations, including review and approval of associated manufacturing and testing records. In addition, they will help maintain the site compliance program, supporting the supplier qualification program through supplier audits and site compliance through internal audits.
The QA specialist will also represent quality on cross-functional and/or cross-company teams for business-critical development projects.
Implement and oversee the quality systems ensuring compliance with all relevant regulatory guidelines, policies and strategies.
Represent Quality during manufacturing operations and be available to resolve issues and provide guidance in a collaborative fashion.
Provide quality and cGMP input and oversight of the manufacturing facility including data integrity.
Generate QMS Standard Operating Procedures (SOPs) to reflect these processes, which are easy to follow and promote both compliance and efficient operations, in accordance with facility requirements.
Review and approve procedures, documents and records (e.g. Specifications, Batch Records, Validation data, QC data, etc.) in accordance with the facility requirements.
Review and approve technical support documentation. (Examples include cleaning, process, method validation).
Generate and approve Quality documents (e.g. Annual Product Reviews, License variations etc.).
Support the Deviation and OOS investigation systems, advising on assessing the impact and approving final reports and associated CAPA
Support the site change control system, evaluating proposed change controls as assigned, making informed assessments of quality the pact of changes.
Support the facility Supplier Management program, including qualifications and re-qualification of suppliers and materials, auditing vendors and providing oversight as required.
Manage the QA responsibilities of external manufacturers of APIs, reviewing deviations and changes at the CMO site.
Support site compliance program, performing internal audits, training internal auditors as required, and implementing audit action plans.
Participate and follow-up in third-party audits and/or inspections carried out at the site by the authorities or clients.
Complete all required QMS assignments (CAPAs, investigations, actions etc.) in accordance with agreed timelines.
Perform production on the line AQLs, and the incoming inspection and disposition of raw materials, consumables, packaging
Assist in the preparation and presentation of GMP training programmes.
Participate in initiatives and action plans for the development of QA and improvement of GMP compliance
Involved in site-wide projects and continuous improvement processes.
Required Knowledge, Skills, and Abilities
5 -10 year's experience working in finished product pharmaceutical / biologics manufacturing, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines.
Demonstrated capability in establishing collaborative working relationships at all levels, regardless of seniority.
Possess fundamental scientific thought processes and demonstrated the ability to apply this to overcome problems. An ability to think strategically and be a 'go-to' expert across the business in the area of expertise.
Recognise areas for improvement and use initiative to implement change programs in support of progress.
Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
Ability to deliver objectives on time, every time, while meeting all compliance and cost targets.
Ability to generate documentation which is of a high standard.
Possess good organisational skills and attention to detail.
Possess good written, verbal and interpersonal communication skills and the ability to effectively interact cross-functionally.
Ability to handle and prioritise multiple assignments, changing priorities and meet deadlines.
Promote strong personality with a positive attitude and approachable
Demonstrated expertise in Data Integrity highly desirable.
Experience in participation in regulatory audits (HPRA or FDA) desirable.
Required/Preferred Education and Licenses
BSc in science discipline required.
Lead auditor certification highly desirable.
Qualified Person experience or educational requirements desirable.
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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Keywords: QA, Quality Assurance, Quality System, CAPA, Auditing, investigations, actions Quality Assurance Specialist
The RFT Group is an Irish recruitment agencyspecialising exclusively in the recruitment of scientists, engineers and executives for the pharmaceutical, biopharmaceutical and medical device sectors across Ireland, Europe and Rest of World.