Quality Assurance Specialist

Panda International; Breda; On-site; EUR 62,000 - 65,000; Full time

Job summary

Panda International in the Netherlands is seeking a Senior Associate QA for clinical supply chain to provide QA oversight on the supply chain of clinical trial products and support the clinical production area. You will work with Global Clinical Supply Chain, Warehouse/Distribution, Production, Site Quality, Clinical Research Management and Regulatory Affairs.

Key duties include batch review for QP certification, approval of clinical label artwork, assessment of temperature excursions, and

Qualifications

• Master's degree in Life Sciences or related field.
• Typically 3 years of QA or manufacturing experience in pharma/medical devices with batch record review and investigations.
• Knowledge of GMP, GDP and/or GCP.

Responsibilities

• Review batches to support QP batch certification per EU/international regulations.
• Approve clinical label artwork.
• Assess temperature excursions during transport and at sites.
• Resolve compliance and quality issues in manufacturing and transport.
• Review and approve minor deviations and ensure procedural requirements.
• Own and generate SOPs and Work Instructions.
• Review SOPs to meet Corporate, Site and Regulatory requirements.
• Prepare monthly metrics.
• Identify issues and work cross-functionally to resolve.
• Support Clinical Packaging and Labelling Operations as QA on the floor; perform pack checks, batch record reviews and issue handling during manufacturing.

Skills

Effective communication

Cross-functional teamwork

Analytical reasoning

Problem solving

Attention to detail

Education

Master of Science in Life Sciences

Job description

As a Sr. Associate QA clinical supply chain, you will be responsible for providing QA oversight on the supply chain of clinical trial products and provide support in the clinical production area. In this role, you will provide QA support for clinical products received and distributed from ABR to clinical sites and depots. You will be in direct contact with a wide range of stakeholders, and be responsible for establishing effective working relationships with key stakeholders including Global Clinical Supply Chain (GCSCM), Warehouse/Distribution, Production, Site Quality, Clinical Research Management, and Regulatory Affairs.

What are your responsibilities?

• Responsible for batch review to support QP batch certification of Investigational Medicinal Product in compliance with EU and international regulations
• Compliance review and approval of clinical label artwork
• Responsible for assessment of temperature excursions during transport and at clinical sites
• Assist in resolution of compliance and quality issues related to the manufacturing and transport of clinical products
• Review and approve minor deviations ensuring all procedural requirements are met
• Owning and generating operational SOP’s and Work Instructions
• Review of SOP’s ensuring that Corporate, Site and Regulatory requirements are met
• Responsible for preparation of monthly metrics
• Identify issues and work cross functionally to ensure a solution
• Support Clinical Packaging and Labelling Operations as Quality on the floor: support with pack checks, batch record review and issue handling during manufacturing. Execute QA compliance checks.

What do you need to be successful in this role?

• Master in Science degree, preferably in Life Sciences or related field.
• Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review, investigations and analytical testing
• Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/or Good Clinical Practice (GCP) knowledge

What will you bring?

• Compliance following attitude with high degree of attention for detail
• Effective communication skills and ability to work in cross-functional teams
• Problem solving skills including critical thinking and analytical reasoning
• Drive for results
• Nimble learner

What you can expect from us

• Gross annual compensation between €61,876 - €65,128 including the 13th month and holiday allowance
• Yearly bonus
• Commuting allowance
• A strong focus on well-being, including access to an on-site gym, vitality programs, and a healthy company restaurant