Hovione is an international company with over 55 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
To reinforce our team we are looking to fill the following position at our Lumiar site:
Associate Performance and Compliance Specialist (M/F)
This person will be responsible to ensure that all Corporate Procedures and General Compendial Methods are compliant with the latest Guidelines and updated as per internally approved changes and available at all sites, and also that the training plan for general requirements for QC staff is up to date with the latest requirements, transversal to all sites and implemented.
Will also monitor performance of QC laboratories, analytical test methods and analytical service providers (outsourced laboratories) and participate in technical meetings (internal and with customers) as Corporate Analytical Chemistry representative, whenever requested.
- Give regular training sessions to keep analytical personnel updated with the general corporate procedures,
the guidelines and general GMP;
- Update transversal general training requirements for analytical staff whenever needed and monitor progress of implementation at all sites;
- Maintain corporate procedures up to date, aligned with the guidelines and ensure that any approved revision is set in place within the timeframes defined;
- Keep up to date the general analytical test methods ensuring that any update described in the Guidelines is immediately shared with the relevant teams of all sites, assessed for implementation at all sites and implemented within the timeframe defined across all sites;
- Follow up on analytical method performance by trending the analytical method performance of validated methods.
- Degree in Pharmaceutical or chemistry areas, or equivalent degree in a scientific area;
- Good understanding and proficient application of Quality requirements, cGMP´s, ICH/CFR guidelines, ISO Standards and Industrial Safety;
- Knowledge and experience in the Analytical Chemistry area;
- Knowledge in information systems applied to analytical laboratories;
- Strong scientific analysis and reasoning ability;
- Good analytical skills;
- Good communication skills;
- Fluency in written and oral EnglishTeam working ability;
- Critical, proactive and creative personality;
- Initiative and dynamism;
- Accuracy and responsibility;
- Self-confidence, independence and organization;
- Training skills.
- Full time opportunity;
- Remuneration and social benefits adjusted to the job function and matching the experience;
- Excellent work environment, with a strong focus on quality.