Associate Director- Packaging Engineerin
Associate Director- Packaging Engineering: Cork. In this role you will be accountable for both personnel and task management and may be responsible for managing people managers. Core Job Responsibilities : • Determine the functions most critical to departmental success and proactively engage these to drive business forward. • Lead multiple components of departmental strategic initiatives. • Provide technical guidance and training to junior group members. • Examine and work to resolve inter-departmental working issues from a broader organisational perspective. • Analyse, revise and develop internal procedures and systems required to ensure GMP compliance. • Manage complex processes across functions and interact effectively with the other team members to ensure product meets regulatory, performance, and cost requirements. • Lead technical investigations and assessment of deviations. • Advise more junior staff or members of project teams in the initiation and execution of new methods, considering economic, regulatory and safety factors. • Present results of work, interpret data, and draw conclusions regarding presented material and nature of work. • Manage the planning and implementation of new site start-ups. • Make recommendations for cost reduction initiatives as related to materials, labour or overhead. • Make recommendations for continuous improvement in all operation processes. • Investigate the feasibility of applying advanced principles and techniques of related engineering specialty to products and problems. • Demonstrate ability to recognise anomalous and inconsistent results and interpret experimental outcomes. • Manage external vendor relationships and negotiate contracts. • Manage budget for pharmaceutical/packaging engineering-related projects and activities. • Lead the day-to-day activities of a team of personnel, which may include people managers. • Manage team of personnel, including hiring, organising and/or conducting training, conducting performance reviews, and ensuring assigned work is performed to required standards. • Work independently on significant portions of projects. • Make contributions to specialist literature and conferences through publication and presentation of technical advances. • Manage activities at third party sites, including providing project timelines, resolving issues, on-site troubleshooting, and providing overall technical support; may negotiate pricing for defined projects. • Coordinate the specification, installation, utilisation, qualification, and improvement of equipment used for solid dose and liquid products. • Approve documents for Regulatory filings, and review filings, including sections from other disciplines. • Identify Bill of Material components for company products. • Project involvement: serve as a lead for large scale cross-functional projects with the ability to identify and adjust for potential issues. Interested applicants should be able to: Ability to identify risks in the business, elevate the issues and propose and defend solutions to functional leadership. Represents the company as a SME across multiple areas. Demonstrate problem solving skills and negotiate with external, partners, production sites and vendors. Participate in business negotiations in support of new projects. Provide expertise and guidance in interpreting and implementing governmental regulations, agency guidelines, and internal policies to ensure compliance at production sites. Represents the company as an SME in regulatory inspections and quality audits, both internal and external. Communication and adherence to timelines is critical. Responsible for independent assessment of issues that may have significant impact on operations or create a significant amount of risk for the organisation. Gather the information necessary to escalate an issue of critical importance or risk to the appropriate levels. Maintain constant awareness of current landscape of the function, and begin to understand the needs of other disciplines. To be successful in this role you should have: In-depth knowledge of Good Manufacturing Practices (GMPs. In-depth knowledge of manufacturing principles, concepts, industry practices, and standards. Strong computer, organisational, and management skills required. Excellent verbal, written and interpersonal communication skills are required. Have and maintain a full working knowledge of state-of-the-art principles and theories, applying such knowledge to the direction that supports the company's interests. Demonstrate technical proficiency and creativity, collaboration with others and independent thought in suggesting new methods, processes, etc. Must think critically and creatively, and be able to work independently, determine appropriate resources for resolution of problems and have strong organisational and planning skills. You should have: At least 8 to 10 years' experience in the pharmaceutical industry and a Degree or Master's qualification.
16 days ago