Manufacturing Specialist - Dun Laoghaire, Ireland
CK Group is recruiting for a Manufacturing Specialist to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract basis.
The Company: Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites.
The Location: This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food.
The Role: The Manufacturing Specialist will function as the Manufacturing point of contact on New Product Introduction (NPI).
Key Responsibilities include:· Develop, review and update production Standard Operating Procedures.
- Develop, review and update master/generic batch records, bills of materials etc.
- Develop, review and update Product Quality Risk Assessments.
- Partnering with key functional groups to drive strategy definition for risk assessments, characterization, validation, regulatory, and filing milestones.
- Lead Product Team meetings.
- Ensure compliance with project milestones such as conformance batches manufacturing, regulatory submissions, and product launches.
- Hold people to account for delivery and behaviours within Product team.
- Function as the site interface between the Product Delivery Teams (PDT's), and ADL Senior Management.
- Author, Reviewing and Approving new training materials.
- Develop, review and update Protocols for manufacturing activities.
- Documentation and approval of protocol deviations for manufacturing activities.
- Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
- Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP's, batch documentation and licences.
- Liaise with Process Development regarding documentation changes in an effective and timely manner.
- Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including batch documentation, bills of materials and SOP's for submission to the Product Lead.
- Provide technical and clerical support to the production team in the preparation of documentation, collation of data.
- Own and lead change controls as required by the NPI Project Team.
Your Background: To succeed in this role you will have significant experience in a manufacturing support role within biotech/pharma environment. You will have a detailed technical understanding of fill/finish operations, experience participating in and leading cross-functional teams and experience in managing multiple, competing priorities in a fast-paced environment.
For more information or to apply for the Manufacturing Specialist position, please contact Natasha Young on 01246 457739 or email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA44542 in all correspondence.