i-Pharm Consulting

Senior Manufacturing Specialist

Location
Dún Laoghaire
Salary
40,000 - 60,000
Posted
09 Jan 2019
Closes
18 Feb 2019
Ref
MSpecialist
Discipline
R & D , Scientific
Contract Type
Contract
Location - Dun Laoghaire, Dublin



Salary - Up to €38/hour



The Manufacturing Specialist will be primarily responsible for:
• 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.
The Manufacturing Specialist will also function as the Manufacturing point of contact on New Product Introduction (NPI) Projects and be responsible for:
• 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 behaviors 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.



Qualifications

Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role



ABOUT I-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics and Senior Appointments.

www.i-pharmconsulting.com

HOW TO APPLY

If you would like to discuss this vacancy further, please call Global Strategic Delivery Consultant Hamish Corson on +44 20 33 26 4116 or email HCorson@i-pharmconsulting.com . All communications will be held in complete confidence. If this role is not suitable, Hamish is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

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