QA Manager

Vor 2 Tagen

Basel, Schweiz Hobson Prior Vollzeit

Hobson Prior are collaborating with a fantastic biotech establishment who are looking for an individual to join on a contract basis. The opening position is for a QA Manager. Our client is focused on finding, developing and commercialising novel remedies.

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

**Key Responsibilities**:

- Plan GMP/GDP agreements working alongside both CMO's and the CMC team.
- Assist with the evaluation and optimisation of the company's pharmaceutical quality system for allocated procedures.
- For this role, you will offer GMP/GDP quality assurance knowledge throughout the development and commercialisation of company products.
- Guarantee all necessary quality actions are initiated and accomplished rendering to the development or commercial phase.
- You will author, evaluate and/or approve internal SOPs and any other GMP/GDP connected documentation.
- Contribute to the optimisation of the quality system by suggesting new processes, tools or modification of current ones.
- Inform the CMC team and management of possible quality, regulatory and lead times.
- Any other assigned duties.

**Key Skills**:

- Able to handle multifaceted projects and prioritise workload rendering to the project importance.
- Capable of working on various tasks simultaneously with competing priorities.
- Interpersonal and influential abilities.
- A self-confident individual who is assertive and able to independently handle multifaceted shareholders/situations.
- Communication skills both verbally and in writing.

**Requirements**:

- Educated to a degree level in a pharmacy, chemistry, or alternative technical/science university master degree level.
- At least 3+ years of experience within various positions such as pharmaceutical product development/ quality control/ analytical development/ chemical production or similar operational positions within a pharmaceutical organisation.
- At least 3+ years of experience within quality assurance of drug substance and/or drug product.
- Expertise and comprehension of drug substance and/or drug product development, manufacturing process, quality control, packaging and delivery.
- An EU qualified person and/or FvP would be advantageous.
- Know-how of cGMP/GDP.
- Capable of comprehending and executing quality standards.
- Fluency in the English language with knowledge in another European language such as German or French.

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.

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