Job Description
Packaging Process Manager, Pharma
Our client is a major multinational pharmaceutical manufacturer based in Dublin now have a permanent role for a Packaging Process Manager for their pharmaceutical business.
This role will provide technical support to CMOs who manufacture and pack pharmaceutical products, ensuring the transfer of packaging processes
The successful candidate will be technical manager for creation of packaging process robustness monitoring plan, process control strategy, and provides technical oversight of CMO sites.
Responsibilities for Packaging Process Manager:
Ensure robust and compliant process performance at CMO during commercial manufacture by use of continuous process verification and Operational Excellence.
Manages CMO selection process – compilation of technical packages, due diligence, generate scorecard ratings.
Provides technical support and leadership in serialisation activities at CMOs.
Deviation Management, including leading technical investigations at CMOs.
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 Manager 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.
6+ years relevant experience in pharmaceutical packaging technology, technology transfer and packaging/manufacturing support/activities.
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 CMOs.
Ability to close-out investigations and deviations at CMOs.
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