Description
Activities will include change control, non conformance investigations, supplier qualification, incoming materials release, batch release, annual product review and validation compliance activities.Main duties and responsibilities:
To provide support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
To carry out tasks related to the administration of site nonconformance management systems including review and/or approval of investigation.
Carries out tasks relating to the management of site change control systems.
Supports system qualification and process validation activities.
Supports GMP training activities.
Carries out tasks related to the administration of site supplier approval systems.
Carries out tasks related to the management of batch records design and approval.
Carries out administration of the SAP Quality Management Module.
Reviews and approves SOPs/work instructions/forms/validation plans form other departments on behalf of Quality Assurance.
Participates in Health Authority and Customer audits on site.
Qualifications and Experience:
ESSENTIAL:
* Bachelors Degree in a scientific/technical discipline required
* A minimum of 2 years' experience in a quality, manufacturing, validation or compliance role within the biological and/or pharmaceutical industry.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
DESIRABLE:
* Experience in development/and or evolution of GMP systems.
* Operational experience.
- Experience in leading a project or team
* Experience in the auditing of external suppliers, contractors and vendors.
This is an urgent position so if you would like to apply or know someone who would please get in touch immediately on .