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.
Hovione is making a definite move into Continuous Manufacturing with a state-of-the-art facility in New Jersey and is now hiring. We are looking for strong professionals for this exciting and innovative project.
We are recruiting for the following position at our U.S. site located in East Windsor, NJ:
Head of Quality Control
The Head of Quality Control will direct all Quality Control site activities, related with testing and release of raw materials, In-process control, intermediates, Finish Products, Stability, reference standards and approval of analytical methods transfers and validations, while promoting a culture of continuous improvement standards.
- Plan and supervise the activities within the QC area
- Propose and control the Operational Expenditure and Capital Expenditure (investment) annual budgets
- Evaluate the performance, training and career evolution of the QC team at least on a biannual basis, and the needs of both team and the materials.
- Ensure proper information flow between the area and the internal and external customers.
- Make sure that all the team members working in the Laboratory is duly qualified.
- Represent the quality control/analytical area or nominate the laboratory delegates on inspections, meetings with clients, external and internal audits and for the Product/Project team meetings
- Review and approve the analytical test methods to be executed in the laboratory
- Approve final product batches
- Handle QC related deviations and the related corrective and preventive actions
- Ensure environmental testing is carried out in accordance to the defined plan
- Assure and promote compliance with Health, Safety and Environment internal policies within the area
- BS in Chemistry/Pharmacy/Chemical Engineering or other related science field and 8 years of experience in the Pharmaceutical or Chemical Industry and having worked in the In-Process control, Release/Stability, Wet Chemistry, Chromatography, Microbiology or Analytical Development areas, with training and experience in GMP and ICH guidelines.
- Management experience in the analytical field
- Laboratory Management experience
- Management experience in the Pharmacopeias regulations application
- Reach regulations policy knowledge
- Management experience in Health Authorities Inspections (e.g: FDA, EMEA, PMDA)
- High level of understanding of GMP guidelines and requirements pertaining to quality control activities to manufacture API and/or Drug Product
- Able to perform tasks in different areas and deliver results.
- Positive attitude towards new activities and technologies within the chemicals/pharmaceutical operations.
- Exciting full time opportunity in a growing Company, using continuous manufacturing technology under a Quality by Design approach in an innovative setting.
- Competitive salary and benefits commensurate with the job function and candidate’s relevant experience.
- Great work environment, with a strong focus on quality and execution of top class science in state of the art equipment.