DirecciónAt Sandoz, our culture stems directly from our long heritage and deep expertise in developing, producing, and supplying generic and biosimilar medicines.
It’s central to how we deliver our strategy, to achieve our patient purpose.
As QA Associate in Sandoz Iberia, you'll be assuring that the product quality conforms with specifications and that production activity is compliant with Sandoz quality policy and GxP requirements.
Ensure that relevant documentation is up-to-date and archived correctly. Ensure thorough GxP know-how and future trends in the field of GxP.
MAJOR ACCOUNTABILITIES
Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are following the Sandoz Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.
Ensure that all drug products are released to the market for distribution in accordance with the registered specifications and with local / international regulations.
Management of Stock Outs and derived actions together with Health Authorities and relevant internal customers (Supply chain, Regulatory, Market access).
Support launches of product in close collaboration with BD&L partner and Local launch coordinator manager.
Medical Device Responsible Person and main contact person for Health Authorities.
Distribution of marketing samples (where applicable)
Raise any issues or instances of instability per the Sandoz escalation policy, and initiate any market action that is required.
Decide escalation to Senior Management Level and lead Global Quality Assessments and manage filing accordingly as well as ensure that Change requests, are managed according to the Sandoz SOPs from receipt, through to the implementation and closure.
Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, follow up the corrective actions. Management of major and critical quality issues (deviations, recalls, counterfeits (including serialization issues) and product tampering, stability failures, etc.
according to the Quality Agreement and the Sandoz Quality Manual. Ensure investigations are correctly driven. Ensure all required actions are taken appropriately and in a timely manner.
Establish and maintain cross-functional contacts with peer organization and authorities and, follow-up quality related developments in the field of pharmaceutical products.
Ensure that coordinated contact is maintained with all parties (the Regulatory Authorities, the local partners and Global QA.)
Sandoz
Sandoz Iberia
