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Sr QA Manager

AGB-Pharma is a fast-growing, international pharmaceutical company, located in Medicon Valley in Lund.

The company was the first pharmaceutical company in Europe to receive approval for treatment with the sleep hormone melatonin for children with ADHD and sleep disorders. Sleep disorders in children with neuropsychiatric disabilities are a very fast growing market segment. In 2021, AGB-Pharma had sales of more than SEK 166 million with products in Sweden, Norway and Denmark. In April 2022, Adaflex® (melatonin) was launched in the UK and more European markets await in the future. AGB-Pharma can be described as a niche pharmaceutical company, with a focus on sleep health and with scientific and medical excellence in the field of melatonin. The company has advanced pipeline projects to further broaden the product portfolio. Here you are part of an experienced and competent team of about 20 employeese, all at a high senior level of knowledge about the company's specific product portfolio. The team has short decision-making processes where each employee's contribution is important for the company's development and results.
Upprättad
Ansökningsfrist
Löpande urval
Förväntad start.
Så snart som möjligt
Anställningsförhållanden
Fast
Antal timmar
Fulltid
Anställning
Fast
Region
Sverige > Skåne län > Lunds kommun
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On behalf of AGB-Pharma, PharmaRelations is recruiting the next colleague to the team - a Quality Assurance Manager. This is a full-time permanent position. The position is preferably based in the office in Lund, but for the right person, alternatives can be discussed. You report to the company's RA Director.

Responsibilities within QA:

  • Implement and maintain a quality management system demonstrating GDP and GMP compliance with international regulations/standards
  • Issue, review and approve Standard Operation Procedures (SOP)
  • Ensure initial and continuous training are implemented and maintained
  • Participate in any recall operations
  • Ensure that relevant customer complaints are dealt with effectively
  • Ensure that self-inspections are performed necessary corrective measures are put in place
  • Ensuring that any additional requirements imposed on certain products by national law are adhered to
  • Serialization: Perform various steps in SSM and TraceLink
  • Evaluate and assess annual Product Quality Review
  • Responsible for CAPA and deviation processes
  • Audit Suppliers

Personal characteristics:

  • Solution-oriented and flexible in mindset and being able to challenge status quo
  • Good at calibrating standards of work and seeing the big picture, not getting stuck in details
  • Ability to independently organising, sequencing, prioritising and carry out given tasks including decision making as necessary
  • Openminded and appreciative towards an evolving and dynamic workplace where cross-functional collaboration and own initiatives are key
  • Ability to work independently with minimal supervision
  • Relationship/experience of regulatory authorities
  • Communicative (written and verbally), collaborative and structured
  • Generous about sharing knowledge and ideas
  • Care for the wellbeing of our colleagues and end-users of our products

Competence profile:

  • Degree in pharmacy, biology, chemistry, pharmacology, or related life science
  • At least 3 years’ but preferable solid experience from life science industry and from managing quality systems within GDP or GMP
  • Experience within Regulatory Affairs is highly preferable but not a requirement
  • Experienced Microsoft Office user
  • Adequate understanding of Artwork maintenance and associated label requirements
  • Languages: English and Swedish fluent in speech and writing
  • Certified or experienced auditor

Why AGB-Pharma?

The team at AGB-Pharma have many years of experience in the pharmaceutical industry, with specific expertise in the company's various areas: Quality, Regulatory, Production, R&D, Supply Chain, Medical, Marketing and Sales. You will have a lot of personal responsibility, and it is an advantage if you feel confident that you have the experience required to take that responsibility. As AGB-Pharma is a start-up company, it is sometimes required that you can put the infrastructure in place to be able to implement your plans.

Last but not least:

  • Fast-growing Swedish pharmaceutical company with headquarters in Lund and Swedish owners
  • Fresh premises in attractive Medicon Village with about 100 other Life Science companies
  • Appeared on the market for a few years, almost a start-up company with an entrepreneurial spirit
  • Many experts and knowledgeable colleagues in the field
  • 1 product registered in many different markets i.e., many different partnerships and contacts within the government
  • Tho company plans to expand in other markets and indications
  • You will find community, team spirit, development opportunities. For us, it is important that you enjoy and have fun at work!
  • Do you want a position where you contribute daily to solutions for children with sleep difficulties and for young people with ADHD? AGB-Pharma now facilitates the treatment of sleep disorders with its first, registered drug for insomnia in children and adolescents (6–17 years) with ADHD
    Turnover> SEK 200 million after 2 years on the market

 

Skicka din ansökan

Application

If you believe you have the experience and qualities we are looking for, please either apply here with a complete application (motivation letter, CV) or contact Kristina Edholm for a confidential discussion (kristina.edholm@pharmarelations.se). Please do not submit any documents via email due to GDPR reasons. Interviews are taking place, so please get in touch or apply at your earliest convenience.

At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, colour, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.


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