My client, a pharmaceutical company based in North Dublin, is currently recruiting for a Quality Control Manager.
This is a full-time permanent position which will report to the Head of Quality.
Job Purpose: To manage the QC department
This person must be able to provide strong technical support, mentorship and supervision for release, stability, and in-process testing and analytical method development.
To be responsible for all aspects of Quality Control relating to the site manufacturing peration, this includes but is not limited to:
· To arrange stability testing in line with the Master Stability List and as per in-house procedures.
· To issue the master stability list on a yearly basis.
· Compilation, review and maintenance of customer’s stability agreements.
· To ensure stability results are inputted onto the stability database in a timely manner.
· To compile the stability reports for the annual product quality reviews.
· Laboratory compliance with cGMP, GLP and relevant Marketing Authorisations.
· To ensure that adequate training programmes are in place.
· Successful Recruitment and Training of Quality Control Staff.
· To undertake to work safely while on company premises, while ensuring the laboratory implements and operates company safety policies consistent with a safe working environment for all staff.
· Drafting, review and approval of method transfer protocols and reports.
· Drafting, review and approval of cleaning validation protocols and reports.
· Drafting, review and approval of process validation protocols and reports.
· Ensuring all instrumentation and equipment is adequately maintained and calibrated in a timely manner.
· Investigation of and maintaining Out of Specifications and Out of Trend spread sheets.
· Preparation and participation in internal self-inspections and customer/regulatory audits.
The Ideal candidate should have:
1. 2 - 5 years’ experience managing a QC department within a pharmaceutical company
2. Experience in the following analytical techniques: HPLC, UV and Dissolution testing.
3. A sound Knowledge of Empower Software.
4. A science degree, preferably in Pharmaceutical Sciences.
Candidates should forward a current CV no later than 16/04/2021
For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 / 0872972916 or e-mail firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671