US-NJ, US Commercial Batch Release Manager 224674BR-MZ
US Commercial Batch Release Manager
East Hanover, NJ
Responsible for the timely review of batch documentation and release of commercial products to the US Market in order to maintain a continuous pipeline flow of quality and compliant products. Ensure compliance with cGMPs, legal and regulatory requirements and the Novartis Quality Manual and Policies.
Ensures adherence to internal/external guidelines, policies, procedures, specifications and regulatory requirements while reviewing batch documentation (mfg. and pkg. records, CoA, CoC, etc.) and releasing batches to the market.
Responsible for the final disposition of finished product to the US market.
Ensures that all GMP s, GDPs and SOP s are followed
Positively interacts with internal and external associates to quickly and effectively resolve issues.
Ensures CPO readiness for all GMP/GDP regulatory inspections.
Addresses deficiencies to maintain consistent resolutions to all batch review and release issues according to GMP standard and Novartis objectives.
Maintain current knowledge of local regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided.
Report monthly Key Quality Indicators (KQIs) related to GMP/GDP activities to CPO QA
Establish and maintain a good working relationship with Supply Chain and External Supply Operations departments.
Act as manager s deputy, when needed
Audits all documentation for accuracy and completeness according to cGMP s and GDPs
Participates on special projects where necessary
Responsible for representing US NCQ on Supply Support Teams
Authors/reviews SOP s
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.
Bachelors or Equivalent 4-Year University required in the Life Science required English 7 plus years of related pharmaceutical experience, strong auditing and Quality Assurance background. Strong interpersonal, written and oral communication skills Strong skills in problem solving and follow up actions. Must have strong computer skills Incumbent must be well organized, flexible and work with minimal supervision.
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