Quality Assurance Specialist

Req ID: R0011266

Novex Pharma Limited is the leading global pharmaceuticals company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmic, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Responsible for inspection and release of production materials, components and chemicals to the Manufacturing facility.

• Perform material holds of non-conforming material when required.

• Ensure the laboratory area is maintained in a GMP state at all times while followingiall EHS guidelines.

• Support execution of validations for lab equipment, Lab methods and/or facility projects.

• Maintain Data integrity and ensure compliance with company SOPs, specifications, FDA, cGLP and cGMP regulations.

• Promote continuous improvements through participation (i.e. team leader/facilitator or major contributor) in the Quality Improvement Program.

• May be requested to train others on department procedures.

• Conduct analysis of written procedures and submit procedural changes as needed to meet corporate, divisional and/or regulatory requirements.

• Participate in internal and external assessments, as required.

• May support Supplier Quality Initiatives

• Initiation of Events Trackwise 8 Quality Systems.

• Ability to Navigate Global Supplier Quality Trackwise (GSQ TW), Trackwise 8 (TW 8), JDE and Laboratory Information Management System (LIMS).

Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills.

Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate.

May be required to work flexible hours and overtime on short notice. Must be able to learn new computer systems and programs, in a timely manner. Must be able to operate a forklift within a warehouse environment.

May be required to work in cold room environments (-20 C +5 C)

May be required to gown into clean room environment, don PPE (such as PAPR, etc.).

Associate degree in business/scientific discipline and three to five years of relevant experience or Bachelor’s degree in the life sciences required.