Job Description
Our client is a major multinational pharmaceutical manufacturer based in Connacht now have a permanent role for a Packaging Process Manager operating within a global function reporting to Director of Global Packaging.
The successful candidate will be technical manager for creation of packaging process robustness monitoring plan, process control strategy, and provides technical oversight of manufacturing sites, including labelling development.
This role will lead strategic iniatiatives within global packaging development and ensuring provision of technical support to to sites who manufacture and pack company products, ensuring the transfer of packaging processes.
Responsibilities for Packaging Process Manager:
Ensure robust and compliant process performance at sites during commercial manufacture by use of continuous process verification and Operational Excellence.
Ensures technical support is maintained and leadership in serialisation activities at sites.
Deviation Management, including leading technical investigations at sites.
Accountable for packaging technology transfer of products, from one site to another ensuring robust technical transfer within budget constraints.
Approves site technology documents such as Technology Transfer plans, Validation Master plans, Process risk assessments etc.
Ensure compliance and security of supply – metrics review, investigation close-out, change control review, APQR review, and process improvement. Implement / Operational Excellence initiatives as necessary.
Works closely with Supplier Relationship Management and project team members in developing strategies and problem-solving efforts.
Responsibilities for Packaging Process Manager:
Bachelor’s Degree in Science, Engineering or similar Technical discipline.
8+ years relevant experience in pharmaceutical packaging technology, technology transfer and packaging/manufacturing support/activities.
Proven leadership exerience, with ability to develop team and function in a global role.
In-depth knowledge of primary and secondary packaging of pharmaceutical drug products with knowledge of global regulatory requirements related to design and control of these processes.
Ability to use statistical software to analyse process related data to determine process capability or for troubleshooting purposes.
Experience with the technical transfer of products to sites.
Oversight to close-out investigations and deviations at sites.
Knowledge of regulations concerning cGMP, manufacturing, packaging, validation, quality systems, equipment innovations, upgrades, and instrumentation.
Excellent verbal, written communications and presentations skills, including influencing skills.
The position will require varying levels of travel.
Please phone Larry on 01-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie