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Analyst - Quality Operations
Sandoz
posted 30d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Summary
Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners Major accountabilities:
- Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows
- Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, etc.) to ensure appropriate execution of service deliverables
- Support to Stability management eg: Draft reports/assessments of temperature excursion assessments (TEA), transport category assignment (risk assessment (TRA)).
- Support to QC release activities eg: Create, modify and review: Inspection Plans, Inspection Lot Numbers, Certificate Of Analysis, Certificate of Compliance, Specifications etc.
- Support to Testing Monograph management eg: Author testing monograph, Perform impact assessments etc.
- Authoring of risk evaluation reports for Nitrosamines both Step-1 & Step-2. Handling of risk evaluation reports with respect to country specific/local ones. Preforming authoring activity in Subway software. Data collection and slides preparation which are required for weekly work stream leads call/Steerco meetings.
- Perform Statistical support, Performance trending and Business support.
- Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements
- Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes
- Learn & develop understanding to generate insights through data and digital
- Provide active support during internal and external audits.
- Adhere to the current GxP and compliance policies of Novartis
Key performance indicators:
- On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects
Minimum Requirements:
- Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute
- Min 3 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
- GxP knowledge, Basic IT knowledge
- Good communication, presentation and interpersonal skills
- Experience of working closely with the global stakeholders
Skills:
- Continuous Learning.
- Dealing With Ambiguity.
- Gmp Procedures.
- QA (Quality Assurance).
- Quality Control (Qc) Testing.
- Self Awareness.
- Technological Expertise.
- Technological Intelligence.
Languages :
- Fluent in English (written and spoken)
Skills Desired
Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological IntelligenceEmployment Type: Full Time, Permanent
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based on 383 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Sandoz Benefits
Submitted by Company
Competitive compensation Pay equity Pay for sustainable performance Differentiated benefits and wellbeing programs Values & integrity Balanced rewards
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