Commercial Quality Specialist
- Loughbeg, Ringaskiddy, Co. Cork, Ireland, County Cork (IRL)
- Negotiable
- Permanent
- Start date: 03 Apr 22
- Ref: 5081998
- qms
- quality specialist
- gmp
- gdp
Commercial Quality Specialist
The Commercial Quality (CQ) team based in Cork, is part of the EMEA Commercial Quality Organisation, and supports the Quality oversight of the supply and distribution of API's and Medicinal Products for two Legal Entities, Janssen Pharmaceutical Sciences UC (JPS) and Janssen Sciences Ireland UC (JSI).
Reporting into the Quality Manager, The Senior Commercial Quality Specialist is responsible for compliance with the elements of the Johnson & Johnson Quality Policy and J&J QMS that are applicable to the GMP/GDP activities the JPS and JSI Sourcing Companies and LOC (JSI only) undertakes.
This position is also responsible for the continuous improvement of the GMP/GDP status of the Irish business.
The Senior Commercial Quality Specialist will provide oversight of quality and compliance metrics for the Sourcing Companies and LOC.
The Job:
Responsibilities:
- Support the business units in terms of quality management and the resolution and communication of quality issues.
- Maintain and implement the Quality system.
- Collaborate with internal and external partners to provide input to new projects and concepts.
- Maintain effective procedures to meet the business needs.
- Where requested, comment on Global or Regional Quality and distribution procedures and documentation.
- Assist in the management and follow-up services for local authority inspections.
- Support and conduct local internal and external quality audits.
- Monitor the Quality System performance versus local GxP and J&J requirements via use of pertinent business and compliance metrics and goals.
- Support the Quality Manager with monitoring and oversight of outsourced activities and compilation of metrics where required.
- Lifecycle management of GMP/GDP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity.
- Ensure appropriate management of the preparation, execution and follow up of Quality Issues (QIs) and CAPAs related to GxP. Provide input to the Quality Manager for the bi-annual Quality System Management Review for CQ Ireland. Collaborate with internal and external partners to provide input to new projects and concepts.
- Support the continuous training programs ensuring they are maintained to guarantee appropriate competence and experience as well as knowledge of and training in GDP for the team and internal partners.
Have you?
- Ability to apply GMP and GDP regulations and international guidelines to all aspects of the position and experience with external regulatory bodies
- Self starter, ability to interpret data and present outcomes
- Excellent interpersonal and teamwork skills
- Demonstrated ability to organize and prioritize workload
- Enjoys working to multiple deadlines in a multifaceted and fast-paced team environment
- Strong technical writing, verbal communication, and problem-solving skills
- Quality Systems experience or other relevant experience including Quality Compliance.
- Computer literate with expert knowledge of Quality database systems
- Strong analytical skills
- External Body Qualification/Certification as Internal Auditor is preferred title
- Up to date knowledge of relevant pharmaceutical legislation and GMP/GDP. Ability to apply GMP and GDP regulations and international guidelines to all aspects of the position
- A minimum of 3-5 years’ experience in a Quality or compliance role within the Pharmaceutical industry.
This is an excellent opportunity to join an established company as it expands its Irish operations. This is a permanent full-time opportunity and comes with excellent salary and full benefits package.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aidan Crowley at 021 4289605 or send your CV to acrowley@berkley-group.com
