My client are healthcare company based in northeast Dublin. They have a portfolio of healthcare products including medicines, medical devices, foods for special medical purpose and foods supplement. The company is accredited to ISO13485, GMP & GDP. Manufacturing activities are virtual; production is carried out by a network of established CMO's. They're looking for a Quality Officer to join them on an initial 12 month contract.
You're a quality professional with at least 2/3 years' experience in a GMP/Medical device environment. You have some experience with regulatory inspections, supplier audits and customer audits. You have a Bachelor's degree in a scientific discipline.
This is an excellent opportunity for a quality-orientated individual with strong capabilities in internal auditing and documentation skills. Experience working in a pharmaceutical company or medical device manufacturing company is essential.
The role offers excellent exposure to Regulatory Affairs/Pharmacovigilance, R&D and Supply Chain as you will be working closely with these departments. You will report into the Quality Manager.
Some of the responsibilities are as follows:
- Working with Packaging Designers and Suppliers, generating new/revised product packaging and labelling artwork
- Maintaining and updating packaging specifications in both in soft copy and hardcopy
- Maintaining and updating Quality Documents associated with product packaging
- Preparation and updating of company SOPs relevant to product packaging and labelling
- Coordinating the review and approval of packaging artwork and labelling in line with Standard Operating Procedures
- Carry-out and co-ordinate assigned internal audits and ensure the review, monitoring, reporting of the inspections. Ensure audit action items are closed within agreed timeframe.
- Assist with audits and checks on suppliers and ensure the review, monitoring and reporting of the audits.
- Assist with preparation for Health Authority and Notified Body inspections and prepare regulatory inspection responses.
- Assist with facilitating inspections of the company by Third Parties.
- Monitoring and reporting Key Performance Indicators associated with Vendors/Suppliers
- Assist with the preparation and regular review of Technical Agreements with all relevant suppliers.
- Maintaining and updating Quality Documents associated with Vendors
- Co-ordinate the dispatch of samples to contract laboratories.
- Ensure complete documentation of testing of products at contract laboratories.
- Perform QA checks on documentation prior to release of products for sale.
- Preparation and checking of Certificates of Analysis.
- Controlling and maintaining the document archive and sample retention system.
- Provide administrative and/or technical support with respect to preparation, assembly, filing and distribution of information relating to product registrations, compliance and pharmacovigilance.
- Assist with the maintenance the product technical documents.
- Assist with the preparation of the Quality Management Reviews and Product Quality Review.
- Ensure that training plans are implemented and training records are maintained.
- Generation and reporting of relevant Quality metrics.
Think the role in Dublin sounds like the job for you? Does your experience sounds similar to the above? Apply with your current CV and we can go through your suitability for the role in more detail upon application. EU Passport / Stamp 4 Visa essential for consideration.
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Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales