QA Manager GxP
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2164 |
| Job Views | 153 |
- Description
- We are seeking applications for an experienced QA Manager for our client, who are a leading biopharmaceutical company based in Dublin.The successful candidate will look after delivery of quality assurance activities at the fill finish facility, making sure products are manufactured in accordance with cGMP, Corporate and Regulatory requirements.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
Provide technical expertise for all QA and compliance topics / issues relating to manufacturing and product supply of drug product.
Acts as quality point person, providing guidance and feedback on quality assurance issues.
Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Clinical and Commercial Operations groups.
Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
Administer the change control, deviation and CAPA systems on site.
Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required.
Actively contributes to continuous improvement activities.
Represent QA during regulatory inspections.
What you need to apply:
A minimum of 7-10 years relevant experience within the pharma industry or a related field.
QP Qualified is wanted.
Strong knowledge of cGMP requirements for pharmaceutical manufacturing required. Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA or other authorities of similar standing.
Outstanding accuracy and attention to detail
Good knowledge of relevant computer packages e.g., Track wise or similar
Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.
3-5 years’ experience in a QA environment in a leadership role.
Brilliant interpersonal skills are required, as is the ability to communicate well, both verbally and written.
