Description
Main Responsibilities:- External Audits of manufacturers of both raw material/finished product items.
- To approve specifications, sampling procedures, test methods, manufacturing procedures, bills of material and written or electronic documents.
- To wirte and review documents relating to change control and deviations.
- Perform material/supplier investigations supporting raw material quality issues.
- Perform change control management of supplier initiated changes.
- May own specifications, non conformance & CAPA records and change records.
- Manage Raw Material reserve samples.
- May own site quality system(s) and standard operating procedures.
- Write, review and approve Standard Operating Procedures in accordance with policies.
- Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems.
Requirements:
- University degree. Engineering or Science related discipline preferred.
- A minimum of 5 years experience of working in the pharmaceutical or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
- Excellent written and verbal communication skills.
- Experience working with dynamic cross-functional teams and proven abilities in decision making.
- Strong organizational skills, including ability to follow assignments through to completion.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations.
If you feel that you would be a good fit for this role please contact Sarah Irvine on or reply with a copy of your most recent CV. If this position is not what you are looking for but you know of someone who would be suitable we offer referral shopping vouchers of €200 so please feel free to get in touch.