Description
A innovative Pharmaceutical company based in Dublin are seeking a Compliance Manager.Job Purpose:
The primary purpose to the Manager, CMO Compliance is to act as a point of reference for Contract Manufacturing Organisations on all quality related issues and projects that impact the supply of products to our worldwide network of customers.
The job of Manager, CMO Compliance involves but is not limited to the following responsibilities and duties;
- Managing the company's sterile and solid dose CMOs ensuring they maintain a level of GMP compliance as expected by the company and Regulatory authorities
- Holding periodic business review meetings with CMOs.
- Acting as point of reference to CMOs for any GMP or quality related issues while overseeing CMO quality systems such as change controls, unplanned deviations and customer complaints.
- Maintaining current CMO oversight system reporting CMO Quality KPI's to the company's senior management
- Conducting external audits of CMOs (as QA lead auditor), ensuring reports are prepared and all post audit activities are completed.
- Ensuring CMO's are adequately prepared for regulatory audits (EMA, FDA, ANVISA etc)
- Acting as QA point of contact for oversight and review of improvement projects at CMO sites.
- Working with Corporate QA to identify potential new CMOs.
- Any other related activities as indicated by the Quality Director.
The successful applicant will possess the following knowledge, skills, qualifications and experience.
- At least 5 years experience in a similar role within an FDA approved facility.
- A minimum of 2 years experience within a "sterile" product manufacturing facility.
- A BSc in a related discipline is a must, with a MSc in Pharmaceutical QA or equivalent a disctinct advantage.
- A proven track record of implementing quality systems to meet best industry practice and regulatory compliance. Must have excellent attention to detail.
- Ability to advise, lead and manage Contract Manufactures on compliance related matters.
- Ability to trouble shoot, identify issues and follow up with corrective actions.
- Experience of carrying out audits is essential (I.E. Supplier /Internal)
- The ability to work well with all key contacts both internal and external to the organisation.
If you are interested in this great opportunity please contact me Anna Mooney or apply below with an up to date CV.