Manufacturing Compliance Specialist

Team Horizon currently has an exciting opening for a Manufacturing Compliance Specialist to work on our client’s manufacturing facility in Sligo on a contract basis for 6 months.  
 
Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.


• The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.


• Excellent career progression opportunities.

 
What you will bedoing:

• Make sure that all products meet the standards required for marketed and investigational drug products.


• Guarantee that products and aseptic process simulations manufactured meet the requirements of the end users, regulatory authorities and of the company.


• Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.


• Deliver quality oversight during the aseptic processing of products.


• Leading in investigations arising out of product or manufacturing processes non-compliance.


• Batch Records, review/audit.


• Manufacturing Logs, reviews.


• Line Clearance completion.


• Incoming Raw Material checks, including product status maintenance.


• Provide Stability Program Support, e.g., sample pulls, weekly checks, protocol generation as required.


• Finished product status maintenance, including labelling as required.


• Administration of Quality Logs, e.g., QA Hold, Sample Request, VCR.


• Lead operations floor daily walk around of manufacturing areas.


• Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.


• Other support as deemed necessary.