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Post : Technical Specialist- MS&T
Job Description
Position Purpose :The Technical Specialist supports the ESO Technical Managers by gathering data, reviewing or writing technical documents related to validation (e.g. process validation, CPV/AMB, cleaning validation, packaging), APR PQR, technical files, product risk assessment. The scope includes all drug products bulk (DP), finished products (FP) and all chemical intermediates/APIs under ESO responsibility. For that purpose, He / She collects data from the CMO (Contract Manufacturing Operation) or Novartis Business Units. For a limited number of products you should also contributes to the product stewardship with supporting ESO Technical Manager in product oversight throughout the lifecycle.
Job Responsibilities :
• Collects and analyze data (i.e. validation, CPV/AMB, APR/PQR, product technical files, analytical and related testing monography) eventually including statistical analysis. Perform reviews against template for completeness of documentations - Provide input and review of such documents against standards and template.
• Discuss and formalize (e.g. technical report) the outcome of the technical reviews Process/product oversight and knowledge.
• Ensures maintenance of the knowledge and the history of the product(s) process throughout the entire commercial lifecycle (i.e. maintenance of technical documentation such as Technical Files or product specific Quality Risk Analysis)
• Collects and examines data to contribute or personally ensure Product Quality Risk Assessment (i.e. HLPA) Continued Process Verification (CPV) and AMB (Annual Monitoring Batch), data trending and statistical analysis.
• Collects and reviews the technical content and scientific rational of CPV/AMB related documentation provided by the CMO (protocols/report, risk analysis).
• Eventually contribute to the writing of CPV/AMB ,validation related documentations.
• Track CPV/AMB parameters shared by the CMOs. Monitor all critical variables and key variables as appropriate for the assigned product(s) (Critical Process Parameters CPP, In Process Control IPC parameters, Quality Attributes, Characteristics of raw materials. etc.) using statistical analysis and conducting regular product specific data trending Investigations/Deviations:
• Invents time in collecting, consolidate and verify data to support investigations/deviation processes.
• Describe & follow-up of CAPA plans Validation: Collect and review and the technical content and scientific rational of Validation related documentation provided by the CMO (protocols/report, Quality Risk Assessment, validation master plan).
• Support Validation Leads and Experts in the implementation and the tracking of Global Validation Program (GVP) and related Validation Plan and Scheduling (VPS) execution.
•Collects and consolidate relevant data for Validation KPI using ad hoc established reporting tools (i.e. dashboard, database) Annual Product Review/Product Quality Review (APR/PQR).
•Contribute to APR/PRQ related activities (e.g. regulatory check, product/process performance review, validation status).
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Candidate Profile :
Graduate in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology English. 5 to 10 years experience in Manufacturing/ Manufacturing Science and Technology/Technical Development/Quality in Pharmaceutical Industry.Deep understanding of manufacturing processes and related process equipment. Strong working knowledge of quality systems and Pharma regulatory requirements across multiple health authorities. Experience in executing process and cleaning validation. Experience in executing process and packaging equipment qualification (primary/secondary on semi-automated/automated equipment) Experience with validation of packaging processes (blistering, bottling, cartooning and hand packaging) of solid oral dosage forms, liquids and suppositories. This includes knowledge of various packaging material types (raw materials), IPC and release test methods for package integrity. Expert in reviewing and writing technical reports. Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions). If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application. Equal Employment Opportunity: 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.
Additional Information:
Job ID: 200779BR
Experience: 5-10 Years
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Technical Operations
Location: Hyderabad
End Date: 22nd December, 2016
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