QA_APQR (Annual Product Quality Review) Compliance Specialist

Job description

Job Description

Local candidates only. No relocation available.

PURPOSE
Responsible for development, execution and implementation of Annual Product Quality Review (APQR) program for CGT Morris Plains operations and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements (US/EU/ROW), the Novartis Corporate Quality Manual and Policies, and site procedures and business requirements. Support Change Control process as QA/QC coordinator.

RESPONSIBILITIES
• Develop, execute and implement a robust and compliant APQR program which meets all regulatory requirements and according to Novartis Corporate Quality Manual and relevant NTO GOPs. • Author the APQR on an annual basis ensuring all elements are included and completed within the regulatory and NVS Quality Manual time lines. This includes data interpretation of analytical, manufacturing, compliance and regulatory data and drawing conclusions from real time data and statistical reports. • Verify the consistency of existing processes and highlight any trends. Provide a documented review of key quality indicators with support of CGT SMEs to determine the need for changes in product or process specifications, manufacturing, or quality procedures and ensuring alignment with filing. • Function as the APQR Quality System/Business Process owner. • Function as Change Control coordinator for QA/QC related activities. Lead change controls from QA/QC providing ownership of changes and oversight of all changes originating from QA/QC organization. • Establish internal process for collection of data and information flow from all key quality systems and sources. This also encompasses relevant CMO, Supplier and Apheresis data and information.
• Establish APQR CGT local business community to ensure all key quality system SMEs and business process owners (BPO) provide data and information on time and in full to meet regulatory and internal timelines. This includes all key functions within CGT and supporting CGT such as Regulatory Affairs and CPO QA operations. • Establish review and verification process with key SMEs and BPOs for the evaluation of trends and determination of CAPAs for inclusion within the APQR. Ensure follow-up and closure of all CAPAs identified and linkage to other quality systems (e.g. Deviation trending reports, etc.) • Establish process with Process Scientist SMEs for how product performance data will be translated/transferred and integrated into the APQR reporting • Implement NTO Global APQR Tool for collection and analysis of data from key quality system applications (e.g. LIMS, AQWA, etc.) to further support the data evaluation process. • Function as the CGT voice/representative and key business user in the NTO Business User Group and for any APQR Business Application/IT updates and/or procedural updates. Ensure the CGT SMEs are engaged in any relevant activities (e.g. new releases, upgrades, enhancements, user requirement development, etc.)
• Provide updates to all relevant quality committees and boards as well as cockpit KPI reporting for on time completion of APQRs. • Create and maintain CGT APQR SOP/WP for managing the internal process, roles and responsibilities as well as interface with CPO QA. Ensure Data integrity principles are built into all data collections, reviewer and compiling processes and procedural controls are put in place to ensure DI is maintained throughout. Align with NTO network to implement the DI standards established. Ensure all SMEs completing activities to support APQR process have completed the necessary NTO and CGT based training. • Coordinate with CMO QA for any relevant common data across the product portfolio to ensure harmonized reporting. • Benchmark with NTO sites and CPO QA for best practices for continual improvement. • Develop meaningful KPIs to monitor internal processes and delivery of information. • Complete annual assessment of health of APQR Quality System.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired profile

Minimum requirements

Education: (Technical) University/academy degree in Biological Sciences, Chemistry, Pharmacy, or Engineering.

Experience: Eight to Ten or more years of professional pharmaceutical experience, with two years of associated Operations experience. At least five years in a GMP environment is preferred.