- Participating in the development and maintenance of quality systems, processes and procedures to assure product quality and safety.
- assisting the quality assurance site manager in preparation for internal/external audits and implementation of corrective actions to address non-conformities
- supporting risk management process throughout the product life cycle and providing senior mgt with key data from RA to help drive decisions.
- Supporting, development and maintenance of product approval/clearance/licensing documentation and notifications as required by global regulatory agencies
- Assist in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
- communicates and implements a strategy to ensure compliance
- responsible for review of batch records in support of disposition of bulk drug substance
- responsible for review of equipment validation protocols and report
- general compliance quality systems management support for the following areas:
- Raw material and solution release
- Review of raw material specifications and solution docs
- Release of single use disposable product to include label reconciliation
- review of temp. charts and docs or temp related excursions
- review and update label issuance and reconciliation process
General QA documentation support to include the following:
- Issuance of batch records and issuance and tracking of log books, lab notebooks and SOP binders
- Scanning and filing of excursion docs and client related batch docs to support batch release
- Develops process improvement plans using a variety of quality and continuous process improvement tools, including but not limited to Six Sigma, Lean Manufacturing, SS, SPC, engineering studies, DOE Gauge R&R, etc.