Responsible for timely and effective GMP review and release of batch record documentation associated with DS, DP, FP (export), and devices under the responsibility of ESO Americas. Compliance oversight for SAP Master Data, SAP Inspection Lot creation, and specification set up. This role will maintain a continuous pipeline flow of quality and compliant products to CMOs, Affiliates, and Global CPOs and is part of cross-functional teams to ensure that SAP data management objectives of ESO are met. The position focus is on batch record review, batch release, batch release optimization; IT data integrity, IT process optimization, and IT tool updates and/or replacement.
Adheres to internal/external guidelines, policies, procedures, specifications, and regulatory requirements while reviewing and releasing batch documentation, including CoA's.
Ensures that Release Authority is approved by QA Lead and in place before completing any technical release within SAP and associated systems as applicable.
Performs Trackwise AQWA and Agile Change Queries and Regulatory DRAGON Compliance Checks as required to support release activities. Audits all documentation for accuracy and completeness and addresses deficiencies to batch review and release activities according to Novartis requirements and cGMP's.
Continuously evaluates and executes improvements/optimization to the batch release process.
Positively interacts with Packaging SRT, CMOs, US Supply Chain, Global CPOs, QAMs, and other internal and external associates to quickly and effectively resolve issues.
Supports FDA inspections and internal audits by supplying information and documentation in a timely manner.
Ensures that any incident/discrepancy affecting product quality is properly escalated according to local procedures.
Updates SAP information and ensures compliance oversight for: SAP Master Data (SAP QM and other module as needed).
Creates new Inspection Lot data and can execute transactions in SAP as necessary.
Supports necessary SAP change requests and performs ad hoc IT tasks which are necessary to achieve the business objectives.
Participates in defining strategy within External Supply for all GMP IT Data Management System activities.
Act as a Key/Super User for all relevant IT systems/Business platforms (e.g. ESOPS, SAP, CCEx, AQWA, DocNav & *EDI (Documentum)) and represent External Supply in the related project teams.
Provides IT guidance to ESO and External suppliers to ensure compliance with Novartis IT requirements.
Creates guidelines, training tools, and templates (e.g. self-explanatory with examples) as needed.
Defines and implements the local IT strategy for data retrieval, storage, and handling.
Evaluates existing IT data, identify gaps, define actions plans within the IT systems to close gaps and report on progress.
Leads and participates on special projects where necessary.
Participates on transfer and launch teams where necessary.
Ensure that all the assigned training requirements are executed and documented in a timely manner.
Participates on the creation and review of SOPs (using ESOPs) associated with the ESO Batch Review Process and IT systems. Escalates issues as applicable to ESO Management through the DRAGON discrepancy, Internal Complaint, ESO Deviation and Escalation Processes, as applicable.
Owner of local SharePoints and shared drives.
Support ESO key business needs as assigned.
Support ESO projects as assigned.
Support SAP Transaction Training, ensuring ESO associates are able to complete all related transactions for technical batch release and required material movements.
Support general documentation needs as required by business.
Support archiving information within DocNav or other IT systems, such as PaperVision. KPIs:
Overall Batch Review/Release TPT (Throughput time)
Batch Record RFT (Right First Time)
CoA Review and Release TPT Customer Service Levels
NOSSCE SAP DRAGON
The number and severity of cGMP issues related to IT Data Management Execution of responsibilities in a timely and efficient manner Performance of External Supply on the established Quality KPIs
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.
BS degree with at least 5 years of pharmaceutical experience. Strong background/skills in auditing, communication, and computer related systems, such as SAP master data and/or transactions. Proficient in local language
At least 5 10 years of related pharmaceutical experience, strong documentation auditing skills and Quality Assurance background. Demonstrated proficiency in computer skills.
Demonstrated cGMP knowledge.
Incumbent must be well organized, flexible and work with minimal supervision. Strong management, interpersonal and written/oral communication, negotiation and problem solving skills.
Must have strong SAP knowledge and understanding of SAP master data set up.
Excellent understanding of GXP Regulations and global Regulatory Guidelines.
Demonstrated leadership and people management skills in a cross-cultural environment.
Ability to work globally to initiate and co-ordinate the work of associates at all levels.
Ability to communicate concepts and ideas verbally and in writing.
Ability to work effectively cross-functionally in a team environment. Considerable organization awareness (e.g. interrelationship of departments, business priorities) including significant
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