Responsibilities: • Responsible for supervising daily activities of the QA team to ensure compliance with company and cGMP standards • Ensures compliance with established internal specifications, standard operating procedures (SOP) and government regulations • Maintains records of incoming material inspection and disposition and represents department in evaluating quality concerns with suppliers • Establishes and maintains a system for 'in time' review of batch records and preparation of release certificates for all market regions • Manages submission of test samples, certificates and batch documentation for authorities (Swissmedic, FDA, etc.) to ensure timely product release • Ensures standard operating procedures (SOP’s) stay current and align with corporate and regulatory requirements Qualifications: • Bachelor degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry) • 5 years' GMP experience in pharmaceutical/biotech/or other regulated industry • Leadership/ team management skills • Knowledge of current Good Manufacturing Practices (cGMP) principles • Knowledge of FDA and EMA requirements Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp .
About CSL Plasma
CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma .
We want CSL to reflect the world around us
As a global organization with employees in 35 countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Plasma!
