Our client a leading Pharmaceutical manufacturer is looking to appoint a Packaging Technologist who will be responsible for provision of Technical expertise with a focus on the Process Development (PD)
and Process Validation (PV) of the Packaging Operations. The role is part of a 'matrix' organisation
and functionally reports to the Technical Manager.
To ensure that operations conducted are performed in accordance with the requirements of the company’s Corporate Standards, Quality System, GMP and GDP Guidelines, Industry Standards & support the Continuous Improvement process.
Duties are performed to ensure:
· A safe working environment is maintained for self and other company employees, ensuring all near miss incidents and accidents are reported in accordance with procedures.
· The Quality of products manufactured and released is assured through adherence to all procedures.
· Opportunities to improve operations and reduce cost are identified and progressed through the continuous improvement and demand innovation initiatives.
· Philosophy of hhc is at the forefront of daily activities.
· All stakeholder and customer expectations are understood and met through communication.
· Performance is in line with personal and company objectives with demonstrated behaviours and competencies.
This position has working relationships with the following:
• Product Champions (PC) and Third-Party Operations (TPO) during development, registration and introduction of pharmaceutical products globally to ensure uninterrupted supply of existing products and successful, on time and on-quality product launches.
• Provision of Technical guidance and expertise on PD & PV to Key Sponsors, Stakeholders and Project teams.
• Regulatory to support Regulatory submissions and generation of filing documents.
• External parties both client and non-client to support manufacturing elements of New Product Technology Transfer.
• External suppliers for the implementation and qualification of new equipment and technology into EML.
• External suppliers for material changes.
• EML management and staff.
• Company manufacturing network (Japan, USA and regional Third-Party Operations).
Details of responsibilities:
• Lead new product introduction onto the packaging lines including define, plan and execute process development and validation studies.
• Lead the qualification of packaging tooling.
• Lead the management of packaging line recipes.
• Lead new packaging material introduction or material changes.
• Lead product or process improvements in packaging.
• Lead Project Management of cross functional teams.
• Lead cross functional teams to deliver work area solutions.
• Lead the generation of Change Controls.
• Lead Deviation investigations including Corrective Action & Preventative Action (CAPA)
• Lead complaint investigation/root cause analysis.
• Lead & support the conduit for knowledge flow between EML and Global forums.
• Lead & support new effective control systems to ensure efficient work practices.
• Lead & support Continuous Improvement activities.
• Lead packaging cleaning development and validation studies.
• Generate & support the introduction of new ways of work.
• Generate Technical reports to support new submissions.
• Generate Technical reports including the interpretation and presentation of Statistical data.
• Generate batch records & regulatory submission documents based on sound knowledge.
• Provide detailed Technical expertise on Packaging Operations.
• Provide Technical support and facilitation of company affiliates, third party operations and supply chain.
• Provide Technical support of EML operations, systems & process.
• Provide an in-depth knowledge of the packaging of pharmaceutical products.
• Support, Develop & Implement Standard Operating Procedures (SOP).
• Support the execution of approved activity in accordance with agreed schedules.
• Support Good Manufacturing Practices in all areas of responsibility.
• Support the completion of all activities in an agreed timely manner.
• Able to prioritise and manage multiple projects and potentially conflicting requirements.
Skills and Qualifications
· Experience in a Pharmaceutical packaging or technical environment performing technical/operations.
· Experience associated to packaging materials, new product introduction and introduction of new packaging lines.
· Practical hands on experience of packaging technology and equipment.
- Demonstrable familiarity of MHRA/FDA guidance.
- Qualification in project management desirable.
· Problem solving and decision-making capabilities
· Professional behavior and self-awareness
· Good communication skills
· Good presentation skills
· Ability to work effectively within a Team
· Effective time management