Location: Portugal - Amadora
Company: OM Pharma
In this role, you work for the Quality Department and report directly to the Validation and Metrology Manager. Your goal is to ensure compliance support to relevant applicable regulations, guidelines and standards. Your main tasks include:
- Participate in equipment qualification (IQ/OQ/PQ)
- Participate in GxP software validations
- Collaborate in Metrology tasks like certificate analysis or calibration activities
- Prepare and review documentation, statistical data analysis, protocol and reports issue
- Establish and maintain strong partnership with internal and external customers and stakeholders
- Support to ongoing site and corporate projects
- Participate in the implementation, maintenance and continuous improvement of management systems
- Support product sampling in the scope of processes and cleaning validation
For this challenging position, we are looking for an experienced and proactive person bringing the following profile:
- University degree in Mechanical Engineering (preferably) or Chemistry, Pharmaceutical Sciences or related technical field
- 3 to 5 years’ experience in a similar position within pharmaceutical or food industry
- Strong understanding of GMP requirements
- Good working knowledge of GAMP 5, 21 CFR part.11, ISO 2859
- Previous experience with IT systems such as LIMS, Trackwise or Minitab
- Fluent in Portuguese and very good knowledge of English both in oral and written conversation
Thanks to your interpersonal skills, you build easily strong relationships with customers and feel comfortable with negociation. You work in a autonomous and organized way that allows you to satisfy your customers’ needs and meet deadlines. You love to coordinate multiple activities in parallel and are open to travel from time to time.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.