Quality Assurance Specialist (m/f) - Genève

For our biotech production site and headquarters in Meyrin, we are looking for a Quality Assurance Specialist (m/f).

Under the supervision of the Quality Assurance Team Leader, you will join a team of 5 people and your mission consists of guaranteeing the quality of the manufactured products and maintaining the site's compliance with GMP requirements, while actively participating in continuous improvement.

Your main responsibilities are as follows: To carry out this mission successfully, we are looking for a person with the following profile:

• Review and approve batch records, manufacturing protocols, qualification / validation reports, maintenance / calibration programs and other associated quality documents
• Prepare release protocols
• Provide quality support in the management of quality events (deviations, investigations, CAPA and change requests) and contribute to their resolution
• Ensure compliance with regulatory requirements and process compliance in accordance with GMP, MA and SOPs and validation files
• Contribute to the preparation and conduct of audits, inspections and regulatory visits
• Participate in the continuous improvement of quality systems and site documentation
• Develop an active field presence in order to promote the quality culture and support operational teams
• Participate in cross-functional quality projects, the monitoring of performance indicators and the training of employees on GxP good practices

To carry out this mission successfully, we are looking for a person with the following profile:

• Higher education in Pharmacy, Biology, Biochemistry, Chemistry or equivalent field
• At least 2 to 3 years of experience in the pharmaceutical or biotechnological industry in a role related to quality or production; good knowledge of manufacturing processes is a real asset
• Solid knowledge of GMP, with a good understanding of pharmaceutical quality systems
• Proficiency in the Ms Office Suite and ERP systems (ideally Sage X3); experience with Trackwise / EDMS / LMS tools valued
• Excellent command of French, both spoken and written; English is appreciated

You describe yourself as a rigorous, proactive and solution-oriented person. A true team player, you enjoy working within a close-knit team and know how to combine assertiveness with a spirit of collaboration. You are able to defend Quality requirements with conviction, while prioritizing dialogue, pragmatism and the search for consensus. Thanks to your analytical mind, your sense of responsibility and your excellent interpersonal skills, you interact effectively with different departments and contribute actively to promoting a strong quality and collaborative culture.

Are you interested in this opportunity? Send us your application as soon as possible and join the teams of OM Pharma!

About Us ###

OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections.
The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.

For more information, visit the website: ompharma.com.