Quality Coordinator / Quality Associate - Frankfurt (With flexy working from home 50%)

Quality Coordinator / Quality Associate - Frankfurt (With flexy working from home 50%)

Permanent

Required language skills: German

About us

With over 30 years' experience in providing first class logistics solutions to the global scientific community, and with experts in the areas of regulatory compliance, temperature-controlled solutions and supply chain we strive to be the best in what we do by partnering with our customers and our suppliers to learn about the key challenges of life sciences logistics, as well as being experts in how cutting edge logistical solutions are being implemented to help improve global supply chains across a range of scientific areas, including cell and gene therapy and clinical trials.

We have considerable investment and as such are growing in size and are looking for a highly motivated Quality Assurance professional to support all business functions to assist us to drive continuous improvement and to support our Global Quality and Compliance manager to help implement and manage our QMS (Quality Management System)

This is a super role and will sit right at the heart of Biocair. By this continuous drive for improvement we will in return be able to develop the right individual to shape your career within the Quality environment and you will help shape the future of Biocair and its growth over the next few years.

You will work as part of a team responsible for activity associated with ensuring that the business is aware of all relevant quality obligations (including Good Distribution Practice (“GDP”) for human pharmaceuticals), providing effective support for activity such as customer audits, supplier audits, internal audits, change control and continual improvement, performance measurement, training, customer questionnaires, quality agreements and validation activities.

Key Responsibilities

Support the business through completion of key quality activities, including;

Document Control – Management of documented information in line with the appropriate procedure, including training and guidance on use of the QMS software platform. Develop policies, Standard Operating Procedures and training materials to raise the level of quality within the work force
Training –Work as part of a team to develop and maintain training and knowledge resources necessary for other departments to meet their quality obligations (including GDP). Provision of training on Quality procedures for appointed region(s).
Non-conformances and CAPA – Support, administration and review of deviations and associated actions to ensure that true root cause is identified and addressed, and that actions are reviewed for effectiveness.
Customer Complaints - Support Operations by providing guidance throughout investigations, assisting with CAPA development and approving handling reports.
Supplier approvals – supplier QA pre-approvals, completion of supplier audits for appointed region(s).
Completion of customer questionnaires.
Completion of self-inspections and audits for appointed region(s).
Support customer, supplier and regulator audit activities either through direct control or through support of other key workers. This includes support with generation of appropriate CAPA, collation and submission of the response, monitoring of CAPA completion, and ongoing communication with the customer, for appointed region(s).

Equipment and Validation:

Work with the Operations units at each site to ensure that the correct equipment is sourced to meet business needs.
Develop and control appropriate validation plans and associated documentation (User Requirement Specifications, Qualification Protocols, reports, Standard Operating Procedures etc.) for equipment at appointed sites.
Ensure that equipment is appropriately qualified through test execution, deviation management and data analytics – either through direct action, working with site representation or use of an approved subcontractor.
Ensure that periodic equipment validation/qualification tasks, such as performance monitoring, servicing, calibration and cleaning are completed in line with approved schedules and procedures.
Maintain (review and approve/reject, management of) records for the repair, maintenance, calibration and validation of equipment including computerised systems. Records must be maintained in an audit-ready state.
Provide subject matter expertise and oversight for other teams regarding validation and approval of Quality records.

Premises:

Ensure storage areas are temperature mapped and subject to appropriate monitoring.
Oversight and review (review and approve/reject, management) of pest control records for appointed sites.
Ensure that appropriate standards of GDP are maintained for own premises through oversight of cleaning records. Work with appointed sites to ensure that standards are understood and maintained. Perform regular spot checks of appointed premises to ensure compliance with standards.
Ensuring segregation, staging and distribution medicinal products remains in line with GDP, through verification that appointed sites are adhering to appropriate procedures.
Complete regular site inspections and audits for appointed region(s). Ensure operational activity does not compromise the quality of medicines and Biocair can demonstrate compliance with GDP.
Ensure that data integrity and the principles of ALCOA+ are observed at appointed sites.
Contribute to formal risk management processes operated by the department.

Knowledge, Skills and Experience

Essential

Experience in one of the following: ISO 9001:2015, Good Distribution Practice, specialist logistics or the Pharmaceutical sector in a Quality Assurance capacity.
A strong interest in process improvement
Excellent communicator at all levels, both verbal and written, with a passion for providing ethical and compliant solutions.
Collaborative approach, working across functional areas and cultures
Intermediate MS Office skills (Excel, Word, PowerPoint, Visio)

Desirable
Experience in conducting and/or hosting audits.

In return you will gain:

You will be part of this super and growing team using your experience & quality creativity to help shape this department and the future of the Biocair business.
We will offer a very competitive salary and flexible benefits in addition to a fantastic place to work and a family feel/ inclusive culture!
A development opportunity for your career in Quality!

For a more detailed job description, please visit our careers website - https://www.biocair.com/careers