Proclinical is seeking a dedicated and detail-oriented Serialization Manager. The primary focus of this role is to ensure the compliance of our products with various national serialization requirements, with the ultimate goal of protecting patients from counterfeit medicines. This role is crucial in maintaining the efficiency and robustness of the processes required for serialization and pack commissioning, ensuring the safe and uninterrupted supply of medicines to patients.
Responsibilities:
- Oversee the operation of the serialization solution platform and coordinate with the provider as necessary.
- Establish and manage serialization connections with contract manufacturer organizations.
- Investigate and resolve issues related to batch uploads and synchronization with the European Hub.
- Act as the primary contact with the European Medicines Verification Organisation, fulfilling all requirements.
- Administer contracts and annual fees with National Medicines Verification Organisations.
- Supervise the handling of serialization alerts, investigate, document, and correct according to best practice guidance.
- Manage product master data and ensure compliance with national and regional requirements.
- Generate EAN numbers as required and ensure the accuracy of product codes.
- Participate in project teams to advise on master data and serialization requirements.
- Conduct training for users of the serialization solution and act as the platform administrator.
- Stay updated on current requirements for serialization and aggregation, advising colleagues accordingly.
Key Skills and Requirements:
- Strong technical expertise in the pharmaceutical industry, specifically in the manufacturing and serialization of medicines.
- Proven project management experience.
- Excellent problem-solving skills and attention to detail.
- Experience working with databases and computer systems.
- Familiarity with GxP environment, experience of Computer Systems Validation is a plus.
- Excellent communication skills, proficient in written and spoken English.
If you are having difficulty in applying or if you have any questions, please contact Ingrid Aymes on I.aymes@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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