Senior Quality Manager to company in Lund!

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Om tjänsten
This assignment as a Quality Manager will start as soon as possible and ends 2020-08-28. You will be a employee at Poolia and then work at a company in Lund. Welcome with your application today, we will work with a ongoing selection.

Dina arbetsuppgifter i huvudsak
• Product Release
• Review batch records, including associated environmental data and NCR/quality incidents.
• Perform specified QC batch inspection to support batch release activities.
• Based on batch record and NCR review, propose batch release and certification to the QP.
• Manage Change Controls at the DVM department, making sure that all changes are assessed for their impact to regulatory compliance and product safety, in accordance with the quality system.
• Ensure all complaints reported by Local Complaint Coordinator are appropriately documented and investigated as required.
• Ensure all complaint investigations content meets cGMP requirements and corporate standards.
• Responsible for ensuring all complaints are closed within the specified corporate time frames.
• Ensure all documentation is relevant and applicable to the DVM process and is periodically reviewed and updated.
• Ensure quality records relevant to the DVM department are reviewed, complete, comprehensive, legible, compliant with good documentation practice.
• Manage the DVM departments deviation process in compliance with GMP requirements and corporate procedures.
• Ensure that all deviations from documented processes are recorded and investigated.
• Ensure that any product affected by a deviation is formally dispositioned, ensuring where needed product is segregated and rejected.
• Ensures no product is released before a formal assessment for the impact of the deviation is made and a disposition approved by the QP.
• Report relevant quality KPI to the Quality Manager.
• Calibration, Validation and Routine Maintenance
• Develope, manage and maintain the validation master plan for the DVM department. .
• GMP and Facilities and Equipment Control
• Ensure all manufacturing operations comply with current GMP guidance.
• Act as QA representative in audit processes relevant to DVM department.
• Regularly communicates with all DVM department staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance.
• Ensures that specific operational training is conducted with DVM department staff to enable them to complete their jobs in compliance with quality systems and country regulations.

Vem är du?
Education/Training Requirements:
• Degree level or equivalent in Pharmacy, Pharmaceutical science, Biotechnology, Chemistry, Microbiology, Engineering or equivalent.

Experience:
• At least 2 years’ experience of working in aseptic manufacturing
• At least 5 years’ experience of quality system implementation and GMP

Field of expertise:
• Aseptic Manufacturing of Sterile Medicines,
• Batch review / release
• Root cause investigation and problem solving techniques
• Quality system management and implementation
• Environmental / microbiological control
• Experience in Facilities and Utilities project validation to include HVAC, Cleanroom, Compressed Air etc.

Technical and Personal skills:
• Report writing
• Problem solving
• Personal accountability and sense of urgency
• Continuous improvement techniques
• Risk management tools and methods

Om verksamheten
Poolia offers a high level of expertise in the core areas of permanent placement and temporary staffing. The permanent placement and temporary staffing services are divided into several specialist areas: Finance & Accounting, IT, Office Support, Human Resources, Sales & Marketing, Life Science & Engineering and Legal.
Another specialist area is executive recruitment through Poolia Executive Search. The Company was founded by Björn Örås in 1989, and in 2015 had just over 1,350 employees in Sweden, Finland and Germany and a turnover of SEK 757 million.