Novartis Pharma Forensics Manager – Application Details
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Job ID 280257BR
Position Title Pharm INT & Forensics Manager
Minimum requirements
Education (minimum/desirable): Pharmacist (with MSc or Ph.D. in Life Sciences, forensics, Pharmacy or Medicines from accredited Technical University) or equivalent education with experience in the pharmaceutical industry.
Languages: Fluent in English
Experience/Professional requirement:
1. 2-3 years’ experience undertaking similar roles in the Pharmaceutical Industry with a particular focus on analytical and forensic sciences as well as technology and quality control. Operational experience should include manufacturing, forensic, QA/QC management, development or other relevant experience e.g. working at a regulatory health authority and/or law enforcement.
2. Sound experience in vibrational spectroscopy (e.g., NIR, FTIR, Raman) and multivariate statistics (e.g., regression analysis for classification or property calibration), machine learning, chemo-metrics.
3. Proficient in computational analysis of field measurement data with Python with data management and integration skills is a plus;
4. Clear record-keeping skills with special attention to data
traceability.5. Experience working in a matrix environment with global, cross-functionally teams;
6. Quick learner, problem solver, working flexibly and in autonomy with solid written and verbal communication skills.
Specific Experience/Professional requirement:
1. Sound knowledge of the enterprise products portfolios (Innovative Medicines and Sandoz).
2. Sound knowledge of multivariate statistical tools and analytical method development and validation.
3. Proficiency in pharmaceutical formulation development and process engineering.
4. Sound knowledge in pharmacopoeia compendia, good knowledge of current legal and regulatory requirements and guidelines (ICHQ8, ICHQ9, and ICHQ10). Comprehensive knowledge of cGMP and cGLP.
5. Profound knowledge in analytical technology and equipment, including qualification and calibration
6. Good know-how in common computer applications, e.g. databases, SAP,MS Office, SharePoint, as well as in laboratory specific applications, e.g. Chromeleon
Major Activities & Accountabilities
1. Contribute to the global management of the differential forensic assessment and testing procedures (TP) of a wide variety of physical pharmaceutical evidence including the management of the evidence’s chain of custody. Ensure that all instrumental, quality, and forensic da-ta are consistent with reported results of analysis. Autonomously perform statistical calcula-tions to verify or validate analysis results as required;
2. Ensure appropriate escalation to responsible management in case of critical findings as per Current valid Standard Operating procedures and work instructions;
3. Run authentication operations to detect counterfeit medicines in fast and real-time detection.
4. Contribute to the management of the overall differential forensic assessment and testing procedures (TP) of a wide variety of physical pharmaceutical evidences including the management of the evidence’s chain of custody.
5. Support operations related to the development, validation, transfer and maintenance of accurate and traceable cross-divisional (group wise) spectral libraries to support the development of robust multivariate/chemometrics statistical methods for reliable, cost-efficient and real-time detection of counterfeit medicines. Support the evaluation of new technologies for counterfeit detections.
6. Provide expert policy advice on all matters related to spectral libraries’ collection, validation, release and maintenance, including Legal and Quality aspects. Use Pharmaceutical intelligence and operational forensics products to influence engagement with internal and external partners.
7. Promote the department in line with the global security strategy by representing Global Security as a trustworthy and authentic business partner that provides essential value-added services.
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