Responsibilities:

• The candidate is responsible for hands on, day-to-day cGMP activities as trained and required per schedule.
• They interact directly with site staff, who are performing the daily operational functions (e.g. manufacturing, QC, etc.), in support of their effort to produce quality products.
• This role ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the PU, QC labs, and other support area ensure adherence to the Client's policies, SOPs, and cGMP requirements.
• Initiation, review and approval of initials & Impact assessment, deviation (with focus on minor and major), quality event and OOS/OOE/OOT investigations and CAPA plan establishment in accordance with applicable SOPs.
• Participates in activities associated with event resolution and CAPAs
• Implements and ensures adherence of appropriate regulations and the Client's quality standards.
• Additional activities may be assigned for training and completion as required.
• Demonstrates and role models the Client's values and behaviors.