Responsible for the provision of Pack Technologist activities supporting development of new and existing products.
Responsible for ensuring that all packaging components are developed to meet Regulatory requirements and conform to specifications and standards
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
Delivering Packaging technology activities on behalf of all Norgine entities for new and existing Norgine Products.
- Responsible for M&S actions aligned to the artwork, production and engineering processes to completion of tasks outlined.
- Accountable for the technical drawing library ensuring that it is fit for purpose for use by the artwork group and external suppliers
- Alignment to Norgine NPDI and M&S supply strategy
- Working on development of packaging initiatives and projects and the impact this has on other Norgine functional areas and processes – e.g. E1, Procurement, M&S Production, Quality, Data Management etc.
- Providing technical expertise to artwork and production teams to ensure product process and commercial supply aligns to the principles of lean process and pack manufacture
- Providing support in managing the supply of commercial product from Norgine sites and CMO sites ensuring no out of stock situation arises as a result of pack technology roles and responsibilities
- Responsible of maintaining awareness of new technologies and regulatory requirements attaining to pack technologist activities.
- Responsible as Packaging Expert for inputting into, raising and managing Change Controls and Deviations associated with packaging matters not considered to be of a complex nature.
- Accountable / Responsible as Pack Technologist to inputting data into IDMP.
- Accountable / Responsible for establishing & maintaining the variable data and recipes required for Serialisation.
- Accountable / Responsible to providing expertise to understand and ensure compliance with GS1 standards
- Accountable as Pack Technologist on the following teams, IDMP, RIM Veeva and Serialisation
- Accountable for meeting KPIs as identified on training records and project requirements including change control compliance
- Design, develop and implement pack designs (technical drawing) for new packs and changes to existing packs. Due consideration and working with engineering personnel to understand equipment requirements and limitations that need to be considered.
- Provide expertise regarding GS1, GTIN & NTIN standards as applicable in packaging especially relating to variable data and recipes.
- Develop packaging components to ensure “fit for purpose” and allow for efficient and cost effective production processes.
- Ensure standard technical drawings are maintained and latest versions are readily available.
- Create new technical drawings when required for any new packaging components.
- Review and uploading technical drawings and artwork onto RIM Veeva as per process implemented.
- Work closely with Artwork house and provide answers to any questions relating to technical drawings.
- Carry out a technical pre-review of artwork (correct drawings, position of pharmacodes, variable data areas, varnish free areas, number of colours etc.). Checking the Artwork team have annotated the amendments correctly and no additional technical changes are required.
- On receipt of PDFs from the Artwork team, check Artwork changes and digitally sign final completed artwork as approved.
- Provide technical support for packaging issues which may include participating in trials – including
- Specification support
- Quality issues
- Engineering support
- Rationalisation of Packs
- Problem solve and trouble shoot in investigations relating to packaging components. Participate in any Supplier, purchasing, materials management, Continuous Improvement meetings to help identify and agree the root cause of any packaging problems.
- To participate in project teams as appropriate (e.g. change in component suppliers, change in materials suppliers, strength and configuration of outer cartons etc.)
- Work with Quality materials management and Continuous Improvement on Packaging Master Specification/Specifications
- Design and Develop Pallet stacking patterns for new and changes to existing products
- Participate as a Member of the IDMP (Identification of Medicinal Products) project team. Attend regular meetings on and off site. Participate in any additional Lync meetings.
- Participate as a Member of Serialisation and Anti-Tampering Device (France) Project teams
- Key member of team who develops packs to avoid “Sunset clause”
SKILLS & KNOWLEDGE
- Institute of Packaging Qualified (Diploma)
- BTEC Pharm. Qualified or degree equivalent
- Comprehensive knowledge of primary and secondary packaging suppliers
- Good understanding of packaging production processes, lead times and costs
- Good influencing and negotiating skills, commercially and financially aware
- Experience in the application of new and existing pharmaceutical packaging process
- Knowledge of GMP and understanding of Regulatory compliance
- Experience and knowledge of Quality Systems and Change Control
- Overall understanding of bar codes used worldwide both national and global bar code types
- Computer Literate with experience of ERP systems and Microsoft applications
- Demonstrate and understanding of Lean 6 sigma tools, and Continuous Improvement orientated
- Operating in a multinational environment
- Act as a go to person
- Scientifically and mathematically minded
- Interested in solving problems
- Able to demonstrate good communication and interpersonal skills at all levels, offering constructive advice as needed.