Are you meticulous in your work and take pride in addressing all the details in what you work on? Have you an excellent track record in working within a certified or regulated Quality system? Then you might be the candidate that BioLamina is looking for! About the position
You will strengthen our Quality Assurance team. The Quality Department at BioLamina is responsible for establishing in-house quality procedures, standards, specifications, systems, and to support other departments to ensure that the operations at BioLamina meet outlined requirements. Since BioLamina is an entrepreneurial company, there will be great opportunities for you to help shape, structure and implement Quality routines at BioLamina. There will also be opportunities to develop your skills in a specialized field such as data integrity, supplier auditing or aseptic filling.
The position is full time and located in Sundbyberg, a close suburb to Stockholm (ca 6 km from Stockholm city), with excellent commuting opportunities (bus, tram, subway and train).Responsibilities
As a QA Manager your main responsibilities will include:
- Contribute to the continuous development of the QMS
- Review and approve quality processes and documentation for deviation management, change control management, CAPA management, supplier evaluations
- Batch records review, approval and subsequently release of product
- Ensure that BioLamina´s products comply with release specifications
- Collaborate cross-functionally and provide QA support to other functions at the company
- Lead and participate in risk assessments of changes and non-conformances
- Organize and participates in internal and external audits
- Provide quality training
- Participate in quality and regulatory discussions with external partners and customers.
- Review and approve qualification and validation documentation
- Author, review and/or approve quality records and documents, such as SOPs, instructions and templates.Your profile
To succeed in this role, you need to have a strong sense of accountability for your work and be able to stand your ground in discussions. An optimistic spirit that contributes to spread positivity energy and focuses on solutions rather than problems will be a perfect match! The role requires you to work independently with short- and long-term deliveries, in collaboration with our QA managers.
Qualifications and training:
– Must fulfill the formal requirements for Qualified Person (QP) according to LVFS 2004:7
– Several years of experience from working in a QA-position is essential (preferably within manufacturing of biotechnological products) including tasks such as change controls, CAPA, deviation management, Supplier evaluations, Customer Complaints handling.
– Must have experience in authoring Quality documents such as SOPs, instructions, audit plans, assessing study plans
– Must have knowledge and understanding of regulatory requirements for GMP
– Must have excellent writing and communication skills in English (equivalent to CEFR C1 level or higher). About the organisation
BioLamina in Sundbyberg is a Swedish biotech company with global clients within research, biotech and pharma. We are a growing team around 60 people working within manufacturing, R&D, Quality and Customer service. BioLamina has over 27 nationalities represented in the company which creates a highly dynamic and inclusive culture. Our corporate language is English.
BioLamina produces and develops premium laminins, which are proteins used in e.g. stem-cell research. Our quality system is developing, and so the entire company, and we’re striving to launch a product line in accordance to GMP within a few years. The company has a certified Quality Management System according to ISO 9001:2015.