*QA Manager Microbial
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AGC Biologics is looking for a QA Manager for one of our QA teams covering Products produced by microbial fermentation, subsequent purification and aseptic filling of the Drug Substance. The position covers QA oversight as required by GMP in a manufacturing facility producing biological APIs. for phase I-III clinical trials and commercial products.
About the Role
As Manager in the QA Mi team, you will have the responsibility for the daily management of a QA team of highly qualified scientists and Subject Matter Experts.
We are actively involved in the constant development within our field and the continuous improvement of our quality system. We ensure that Manufacturing, Process Development/Transfer, Validation and Quality Control comply with the standards for cGMP production, i.e. EU GMP, 21 CFR and ICH guidelines, and you will be an important collaborator in defining worldwide policies. Additionally we currently focus on optimization and improvement of our release procedures using a risk based approach as well as LEAN principles.
You will cover strategic and tactical leadership for the team responsible for processes, procedures and policies for batch disposition as well as all deliveries leading up to batch disposition such as deviation handling, Change management, approval of production records, QA Shopfloor activities etc.
Your main role will be to lead, coach and support the team-members as well as distribute tasks within the team. You will be the team representative in the contact with all internal and external stakeholders. One of your main priorities will be to ensure that timelines for deliverables are consistently met.
As Manager for the QA Microbial team, you will report to the Senior Director in QA Operations.
About the Team
The Team currently consists of five experienced QA scientists. The team-members are self-driven, highly motivated and capable of working independently. As the team-members all have various previous GMP/Pharma experience, there is a lot of knowledge accumulated within the team.
The most important day-to-day partners for the QA microbial team are Manufacturing, MSAT, and the QP-team.
You are expected to be the front person in establishing a strong Quality Culture in the QA Microbial team and to work across QA, QC, Development, MFG and process validation to ensure collaboration between the stakeholders.
A large part of this role will be the responsibility for ensuring the timely release of commercial and clinical products according to regulatory requirements as well as to foster an understanding of the specific requirements for the supply of API.
PRINCIPAL RESPONSIBILITIES:
Key Words:
- Management and development of the QA Mi Team
- Compliance to regulatory requirements
- Release Process optimization
- Global QA Alignment
- Customer Compliance alignment
- Audit and Inspection readiness, preparation and execution
- Customer Meetings (Corporate, QA/QA, Core team)
- Overall Compliance
- Global Alignment of policies
- Overall compliance alignment with MFG
- Customer compliance interaction
- Batch release process optimization/LEAN Current processes
- Customer KPI Communication
- Daily management and development of the team
- Alignment between QA and QC tasks
KNOWLEDGE, SKILLS & ABILITIES:
- Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/ Biotechnology Industry
- Ability to understand and apply GMP regulations as they relate to manufacturing, QC analytical testing, and facility operations, deep knowledge of Biologics manufacturing is an advantage
- Strong interpersonal, written and oral communication skills
- Strong problem solving skills, including having a pragmatic approach to problem solving
- Experience of department management.
EDUCATION/EXPERIENCE:
- M.Sc. in chemistry or life sciences or equivalent experience
- 10+ years of relevant experience in a pharmaceutical or FDA/GMP environment
- Direct Experience leading QA teams
- Management experience, including a demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, and results-orientated
Please be aware that we take in consideration only the applications send via our career page and, not via email. We will process applications as they arrive.
Want to keep posted about our growth and to learn more about our company?
We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !
AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 6.10.2023, men kan have været deaktiveret og genaktiveret igen.
- Produktspecialist
- København
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