Packaging, Master Data

1 week geleden

Leiden, Zuid-Holland, Nederland Pharming Group Voltijd

About Pharming
Pharming Group (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.

Our Culture
Pharming is committed to our core values: "We Care, We Collaborate, We Walk the Talk", which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.

Purpose of the role:

The Packaging, Master Data & Artwork Specialist will play a crucial role in ensuring the accuracy, compliance, and efficiency of packaging and labelling, master data, and artwork within our pharmaceutical manufacturing and supply chain operations. The Packaging, Master Data & Artwork Specialist will collaborate closely with cross-functional teams including our third-party vendors to manage packaging projects, maintain master data integrity, and uphold regulatory requirements. You will implement and maintain both product and artwork configuration in several quality-controlled systems ( SAP, Master Control), including the operational management of third-party vendors involved in the creation thereof. And you'll be responsible for coordinating Finished Product manufacturing, ensuring product availability, and maintaining compliance with regulatory standards. You ensure that current and future products of Pharming (manufactured and/or sold) can be produced and distributed following the GxP guidelines, with the goal to improve quality of life of patients.

Responsibilities:

Finished Product Packaging Management:

Manage the end-to-end Finished Product Packaging, including procurement, inventory management, and distribution processes. Run the Sales & Operations Process to support the mid to long-term decision-making process. Be the first point of contact for our FP packing providers.

Forecasting and Planning:

Utilize forecasting models and demand planning tools to anticipate inventory needs and optimize supply chain efficiency. Create a mid to long term manufacturing plan and identifies associated threats and opportunities

Packaging Material Management:

Coordinate the procurement, inventory control, and distribution of packaging materials for various pharmaceutical products. Ensure packaging materials meet quality standards, specifications, and regulatory requirements. Monitor packaging inventory levels and collaborate with suppliers to ensure timely replenishment.

Master Data Management:

Maintain and update master data related to products, packaging materials, specifications, and production processes in SAP 4HANA. Ensure accuracy, completeness, and consistency of master data records, within key systems (SAP, Master Control) of Pharming and its third-party vendors. Implement data governance policies and procedures to enhance data quality and integrity. Assisting in the application and implementation of procedures for data standards and guidelines on data ownership, coding structures, and data replication to ensure access to and integrity of data sets.

Artwork Development and Approval:

Collaborate with internal stakeholders, including regulatory affairs, marketing, and production teams, to develop and review product and packaging artwork designs. Ensure artwork designs comply with regulatory guidelines, branding standards, and customer requirements. Facilitate the artwork approval process, including coordination with external vendors and regulatory authorities.

Serialization:

Based on defined release and decommissioning processes in the key systems setup, maintain and decommission master data. Be the first point of contact for our Serialization providers.

Industry Standards and Regulatory Compliance:

Stay abreast of regulatory requirements, industry standards, and best practices related to pharmaceutical serialization, packaging and labeling. Support regulatory submissions by providing accurate and up-to-date packaging documentation and information.

Continuous Improvement:

Identify opportunities for process optimization, cost reduction, and quality improvement in packaging, master data management, and artwork development processes. Participate in cross-functional teams and projects to implement best practices and drive continuous improvement initiatives.

Your profile:

Minimum of 7 years of experience in pharmaceutical packaging, artwork, master data management and supply chain or related roles in a global pharmaceutical Proven experience in pharmaceutical supply chain management, with a deep understanding of industry regulations and best practices. Bachelor's degree in relevant area (for example: packaging engineering, industrial engineering, pharmaceutical sciences, or a related field) Proven experience in pharmaceutical finished product packaging, master data and artwork management, with a deep understanding of industry regulations and best practices. GxP knowledge of Manufacturing, Distribution, Documentation, Clinical. Strong understanding of finished product packaging, packaging materials, labeling requirements, and regulatory standards (, FDA, EMA, ICH). Proficiency in SAP S4HANA, supply chain management software and advanced Excel skills. Knowledge of Lean Six Sigma principles and continuous improvement methodologies is a plus Knowledge of project management principles and experience project management. PMI / Prince2 certification is a plus. Fluency in English, and ideally Dutch

What you'll get in return
We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including:

A highly competitive salary holiday allowance (for NL) A minimum of 30 vacation days An excellent pension plan Commuting allowance

You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs. Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all "Pharmers".

Also important We truly value a healthy life-work balance with a lot of flexibility.

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