Quality Assurance Manager

Role & Responsibilities

• Leading & Managing QA Department.
• Handling Quality Audit
• conducting quality related training.

• Perform timely review in accordance with the MA and with the approved analytical method of QC analytical data originated at the testing site and timely preparation and issuance of COAs used for batch certification by the QP.
• Act as SME during evaluation and review of product related change controls, deviations, out of specifications, complaints, regulatory queries, method transfers and analytical method validations in regards to analytical testing, and quality control of drug substance, intermediates drug products finished products. The QA manager shall author scientifically sound deviation investigations and assessments and recommends effective corrective actions as appropriate.
• Maintain oversight and management of stability studies executed by the testing labs, including preparation/review of stability protocols, raw data and review/preparation of reports while ensuring proper follow up at the testing site of timely execution of testing plans as per scheduled time points.
• Liaise with external Analytical testing lab for ensuring testing of GMP analytical samples in accordance with approved specifications while maintaining as well oversight of on time testing and execution of stability sample testing.
• Skilled in trouble shooting and support in investigations.
• Creation, review and maintenance of testing analytical methods and specification ensuring compliance with validation studies and with the marketing authorizations while ensuring proper communication with the testing labs upon receipt or generation of change controls affecting approved analytical methods or relevant specifications.
• Preparation, review and assessment of routine trending of stability data collected for new and annual stability programs and ensuring immediate notification to the Quality team/QP in case of observed trends or suspected out of specifications.
• Support/author analytical technical assessment as required for supporting deviation investigation or other relevant studies.
• Support with preparation of PQR from QC perspective in regards to continuous analytical trending and assessment of analytical data.
• Support the maintenance and update of QA/QC quality management system.
• Support the timely implementation of global standards and procedures in the local units by execution of associated GAPs assessments against local procedures.
• Act as initiator and reviewer of local standards to ensure timely and appropriate review and approval of controlled documentation part of the QMS.

Skills: data,communication,oversight,maintenance,management,specifications,quality assurance manage,preparation,case,testing,assessment