Feeding the world through healthy animals! This is the mission to which Dopharma has been committed for over 50 years. Our French site was founded by three vets from the Ancenis region, who were keen to provide the best possible support for livestock producers. Today, more than a hundred products are produced and packaged at Saint-Herblon, 30 minutes from Nantes.
Dopharma France is now a major veterinary pharmaceutical laboratory in the animal health sector. With around a hundred employees, the company brings together R&D, production and marketing in France and abroad on the same site.
This is a company on a human scale, which has managed to retain its deeply family-oriented character, based on a strong sense of conviviality and closeness between everyone, and strives to combine the achievement of ambitious objectives with the professional and personal balance of its employees.
We are looking for a Quality Assurance Engineer. Reporting directly to the Pharmaceutical Manager
Manager, your role will be to ensure compliance with GMP for the sterile sector.
Duties & Responsibilities
- Leading, advising and providing quality support for all production-related activities in the sterile sector (documentation, deviations, CAPA, etc.).
- Alerting you in the event of regulatory non-compliance with GMP standards and taking the necessary measures, where appropriate in conjunction with your line manager.
Guaranteeing the quality system assigned (APS, Deviations, Change control, RQP, etc.) - Carrying out and maintaining quality risk analyses for the sector
- Communicate on quality issues with customers and subcontractors in relation to the defined product category, to answer technical questions within his/her area of expertise
- Be proactive in the planning, drafting and monitoring of validations of equipment, processes and cleaning in the workshops within his/her area of competence.
- Provide support during regulatory inspections and customer audits
- Carrying out internal and external audits
- Coordinate and lead the activities of the QA team in support of the Quality Assurance Manager
Profile
- 5 years‘ higher education (engineer, pharmacist, etc.) in Quality Assurance for healthcare products or at least 3 to 5 years’ professional experience in a pharmaceutical industry. Experience in the sterile sector of the pharmaceutical industry would be a plus.
- In-depth knowledge of pharmaceutical standards, particularly GMP.
- Planning, rigour and autonomy in the tasks to be carried out
- Ability to work in a cross-functional team and to set high standards
- Ability to coordinate/lead a working group
- Team spirit and teaching skills
- Ability to take decisions
- Good command of office software (Word, Excel)
- Fluency in English for exchanging, drafting and understanding complex data.
Benefits
- 26 days‘ paid annual leave and 16 days’ leave with pay per year
- Health insurance for you and your children to ensure optimum coverage of healthcare costs
- A monthly contribution towards transport costs
- luncheon vouchers worth €5 per day
- Access to an ESC: gift vouchers, holiday vouchers, tickets at preferential rates
- Time for sharing: participation in sporting challenges, end-of-year parties, team lunches, etc.
- A pleasant workplace surrounded by greenery and calm, organized premises
- A close-knit working environment that facilitates discussion, decision-making and project implementation
How to apply? Send a letter to [email protected]