QA Manager

Hobson Prior are currently seeking for a QA Manager to join a fantastic biotech organisation on a contract basis located in Pratteln. Our client is focused on evolving and commercialising novel treatments to aid as many people as possible.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- For this role, you will be responsible for informing the CMC team and handle possible quality, regulatory and lead time matters.
- Offer GMP/GDP quality assurance experience throughout the development and commercialisation of the organisation's products.
- When required, you will support in the oversight of GMP/GDP inspections at third party sites.
- You will guarantee all necessary quality actions are initiated and accomplished rendering to the development or commercial phase.
- Partake, serve as a delegate and defend quality actions within CMC team meetings.
- Assist in evaluating and optimising the company's pharmaceutical quality system for allocated procedures.
- Contribute to the optimisation of the quality system through suggesting new processes, tools or altering current ones.
- To guarantee that quality is comprehended and handled by all shareholder during the product life cycles, you will form a quality risk management tactic based on six sigma notions and training.
- Plan GMP/GDP agreements when cooperating with CMOs and the CMC team.
- Any other assigned duties.

**Key Skills**:

- Social and inspirational skills with the ability to handle various tasks simultaneously with challenging priorities.
- A self-confident individual who is assertive and independent to handle multifaceted shareholders/conditions.
- Communication skills both verbally and written in a professional manner.
- Able to handle multifaceted projects and prioritise workload rendering to the importance of the project.

**Requirements**:

- Educated to a degree level in a pharmacy, chemistry or similar technical/science discipline.
- At least 3+ years of experience in various roles such as pharmaceutical product development/quality control/analytical development/chemical production or similar operational roles within a pharmaceutical organisation.
- At least 3+ years of experience in quality assurance of drug substance and/or drug product.
- Know-how and comprehension of drug substance and/or drug product development, manufacturing procedures, quality control, packaging and delivery.
- Qualified Person EU and/or FvP would be advantageous for the role.
- (c)GMP/GDP's knowledge.
- Capable of comprehending and executing quality standards.
- High capacity to initiate and guide quality actions.
- Fluency in the English language with knowledge in another European language such as German or French would be beneficial.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.