Quality Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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Job Description:

J&J Innovative Medicine is recruiting for a Quality Specialist reporting to the Quality Executive and to be based in Madrid (Spain).

Role responsibilities:

The Quality Specialist is trained and qualified to support the Commercial Quality Department performing some of the necessary activities within the Quality Management System in compliance with internal policies, current local regulations, good manufacturing practices and good distribution practices. These activities include but are not limited to:

• Good distribution practices: executes all activities required within the Quality Management System to ensure compliance with Good Distribution Practices.
• Controlled substances management: performs the activities required to ensure compliance with local legislation regarding controlled substances such as: review, reconciliation and reporting of narcotic vouchers, management of customs documentation, review and generation of monthly reports, management of import authorizations, management of documentation of the destruction of controlled substances, etc.
• Product Quality Complaints and Technical Queries management: involvement in supporting compliance activities related to the call center in place for product quality complaint and technical queries management, such as daily monitoring of activities, performing and documenting mock call and mailboxes review, analyzing the quality of the responses and other factors according to the corresponding SOPs, performing the reconciliation of the different sources of information, managing the delivery of product quality complaint samples, etc.
• Handling, Storage and Distribution activities: Support the documentary processes related to the storage and distribution of products of the Local Operating Company, such as but not limited to: Product receptions review according to SOPs, Non-Conformances and actions related to the product receptions review, Issue management, returns and destructions management, support in custom clearance operations, distribution complaints management, etc.
• Quality Management System maintenance: Perform impact and risk assessment analysis; manage and review Standard Operating Procedures; collaboration in the preparation and execution of audits and inspections; support in the collection and monitoring of quality metrics and KPIs; management of Non-Conformances, CAPAs, Change Controls, and other QMS elements; preparation of EPR reports; management of serialization activities; etc.
• Temperature Excursion Management: perform the evaluation and document the temperature excursions occurring during the distribution and storage and at customer level.
• Support in Tender management: preparation and review of technical documentation required for public tenders.
• Support in managing Medicines under Special Situations: Manage and import authorization with the local Health Authorities, stock management in the HA system, order monitoring, etc.
• Other activities: Any other activity required AdHoc, related to the local QMS and Product Quality Assurance.

Minimum qualifications:

• Bachelor’s degree in pharmacy.
• Minimum 2 years’ experience in the pharmaceutical industry in Quality or any other technical departments (Regulatory, Pharmacovigilance, etc).
• Fluent English (C1) with strong written and verbal communication skills.
• User-level knowledge of Microsoft Office (Word, Excel, Outlook).
• Knowledge of Pharmaceutical Industry, Good Manufacturing Practices and Good Distribution Practices.

Additional qualifications (desirable)

• Master’s degree in Pharmaceutical Industry

Other requirements:

• Strong initiative and ability to work effectively in a team.
• Proactive, attentive to detail and technically oriented.
• Responsible and committed to quality and compliance.
• Effective communication skills.

Required Skills:

Preferred Skills: