Job Description Summary
Significant, broad technical experience in Analytical Testing of in Pharmaceutical Industry or Research (Pharmaceutical Development and/or Quality Control). Demonstrated knowledge and experience with cGMP requirements, Analytical method validation, method development/remediation, re-validation, transfers
Job Description
Major accountabilities:
Significant, broad technical experience in Analytical Testing of in Pharmaceutical Industry or Research (Pharmaceutical Development and/or Quality Control). Demonstrated knowledge and experience with cGMP requirements
Applied knowledge and experience in analytical tools and testing strategies used in QC laboratories (e.g., HPLC/UPLC, spectroscopy)
Experience with risk assessment and risk management tools and approaches
Experience in an area outside of analytics (e.g., formulation development, manufacturing, regulatory, quality systems, or technical operations)
Define improvements in Analytical Methods -Product and process validations
Define improvement areas in process and products
Investigation of Deviation, OOx, Complaints
Define and implement CAPAs
Support transfer projects and validation studies. Prepare protocols and reports for AS&T related tasks (method development/remediation, (re-)validation, transfers)
SOP revisions
Ensures close collaboration with Quality control
Ensures effective and reliable pharmacopeial surveillance for USP, PhEur, and BP within Sandoz by working together with Global AS&T
Supports modernization initiatives in QC testing (automation, digitalization) by appropriate validation or cross-validation where required
Ensures current standards, procedures, Quality modules and global SOPs for the laboratory being followed as required by cGMP. Supports further development of these guiding documents
Minimum Requirements:
Work Experience:
- 5-10 year-experience in Pharma/Manufacturing sector in analytical lab in.
Skills:
- Agility.
- Business Strategy.
- Continuous Learning.
- Dealing With Ambiguity.
- Knowledge Of Gmp.
- Laboratory Excellence.
- Quality Control.
- Root Cause Analysis (Rca).
- Self Awareness.
- Smart Risk Taking.
- Stakeholder Management.
- Technological Expertise.
- Technology Transfer.
Languages :
- English.
Skills Desired
Communication Skills, Continuous Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management
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