about 1 month ago
Hamlyn Williams have partnered with an internationally recognized biopharmaceutical company who are going through a rapid phase of growth. The company specializes in the treatment of severe diseases with specific areas of focus within neurology and immunology disorders.
As a result of company growth, we are looking to fill a QA Manager position on a perm basis. This will be an independent role as part of a growing and dynamic quality assurance team, reporting directly to the Head of Biologics.
** English speaking role **
Responsibilities will inlcude:
- Approve all operational procedures/instructions specification & master production instruction with the potential to affect the quality of the product.
- Review & approve of validation protocol & reports, study protocol & reports to support Capital or key site projects as required
- Making sure that there is stability data to support retest or expiry date, storage conditions
- Support inspections and audits from external parties (e.g. FDA, IMB, EMEA or alliance partners).
- Participating in internal audits as required
- Participate in the preparation/review of regulatory dossiers.
- Establish and maintain support and key liaison representative with Third Party Managers
- Oversee key quality systems such as (CAPA /ER report system, Change Review Board system etc..)
- Ensure that all parts of the QMS are adequately resourced with competent personnel and suitable / sufficient premises and equipment.
- Ensure continued and adequate supplies to the market, such that the patient needs are covered and that any anticipated restriction in supply is escalated to the relevant competent authorities in a timely manner
Specific requirements for this position:
- Biologics background
- QA experience-minimum of 5 years
Attach an updated CV to be considered