quality assurance and clinical operations.

OBJECTIVES:

This role is accountable for batch disposition for Clinical Trial Materials manufactured
The scope includes Drug substance, Bulk Drug Product, Finished Drug Product, Clinical Packaging and labeling
The employee will work with our external CMO partners and internal Quality teams within R&D GMP Quality. In addition this functions works closely with Clinical Supply, Regulatory Affairs, Technical support, external QPs and any stakeholders involved in external supply

ACCOUNTABILITIES:

Performs or supports the execution of the following activities:
Ensure consistent application of quality compliance by aligning daily responsibilities with the appropriate cGMP regulations for US, EU and Japan.
Responsible for reviewing batch documentation, data, certificates of analyses, technical reports
Facilitating, approving and providing inputs into deviation investigations, change controls, CAPA, investigations and nonconformance reviews as required
Supporting batch disposition processes as required
Participate as an integral member of the Inspection Readiness team and support during all internal, vendor and Alliance/Corporate Partner compliance or regulatory audits/inspections of R&D Quality & Clinical Operations departments.
Identify and escalate regulatory issues and trends pertinent to management, as appropriate.
Receive overall project direction from leadership while completing most work independently.
Complete required training and keep training files current.
Additional tasks and duties as assigned.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Bachelor of Science (BS) degree and 3+ years’ exper

SKILLS:

Excellent organizational, presentation development and delivery skills.
Proficient computer, verbal and written communication skills.
Strong problem solving and data analysis skills.

Not Required

Universidad