QA & Compliance Officer

Role Details

We are looking for a Quality Assurance Officer (temporary role) to join our Accord Healthcare team in Barcelona.

• Carrying out quality assurance activities related with the distribution of pharmaceutical medicinal products in the European Union for which Spanish Affiliate (Accord Healthcare SLU) is the Marketing Authorisation Holder
• Building and maintaining good working relationships with external partners such as Wholesalers and Distributors, in addition to Accord Healthcare SLU customers.
• Providing support to internal stakeholders and to tasks related to the Global Quality Management System implementation at Spanish affiliate.

The Role

• Manage and maintain an effective and compliant Quality Management System for Accord Healthcare SLU.
• Assist in the quality assurance policies and procedures.
• Manage of local Change Control, Deviations and CAPA processes.
• Handle of product market returns, liaising with appropriate Wholesaler´s personnel to reject or return the product to the saleable stock.
• Review and track Annual Product Quality Review.
• Collect and compile statistical quality data, monitor and perform trend analysis to support Management Review Process.
• Preparation of batch documentation and associated quality assurance activities in support of Responsible Person batch release to market.
• Handle of customer complaints, co-ordinating local investigation to progress complaint closure, and any subsequent field corrective actions/ recalls.
• Provide support to internal stake holders, in particular to Marketing, Sales and Customer Service departments.
• Review of product packaging material in compliance with the product marketing authorization.
• Manage shortages notifications of Accord products and maintain smooth communication with the Health Authorities.

Core Competencies

• Problem Solving: Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers.
• Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.
• Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities.
• Peer Relationships: Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.

The Person

• At least 2 years’ experience working in the Quality Assurance department of a pharmaceutical company.
• Knowledge of Quality Assurance principles, concepts and standards, as well as knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements within the EEA.
• Knowledge of Spanish and European regulations on QA / regulatory affairs
• Good understanding of market dynamics and requirements in Spain.
• Experience from an international work environment.
• Ability to demonstrate high organization skills, and with good attention to details.
• Excellent team player with the ability to establish and maintain effective working team relationships

The Rewards

How to Apply

A Bit About Us

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All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

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