Partner of choice in specialty, hospital, and rare disease medicines
Senior Executive, Compliance
Location
India
Posted
5 days ago
Salary
0
Seniority
Senior
Job Description
Senior Executive, Compliance
ADVANZ PHARMA
• Owning Compliance related change controls pertaining license updates and ensuring such changes are progressed and closed within timelines. • Establishing business and Quality needs and criticality for identified license non-compliances and closing license gaps as dictated by this information. • Writing supporting Quality related submission documents, as necessary. • Managing workload appropriately with the ability to re-prioritize rapidly as necessary. • Liaising with Regulatory routinely to ensure submission priorities are aligned and quality critical submissions are prioritized. • Reviewing and approving critical Module 3 documents written by Regulatory prior to submission to ensure content is CTD compliant. • Managing associated submission RFIs within timeframe. • Quality Compliance owner for Technical Transfers projects, involving performance of gap assessment between prospective CMO and current registered information and working toward established project timelines. • Liaising with external stakeholders including Contract Manufacturing Organizations and building key relationships. • Quality Compliance SME for Projects owned by both the Compliance team and other departments.
Job Requirements
- Minimum Degree in Chemistry, Pharmacy or Microbiology
- Minimum 5 years' experience of working in a similar role within a pharmaceutical industry
- Extensive GxP knowledge across all dosage forms
- Experience in authoring Module 3 in CTD format
- Experience in interpreting manufacturing and testing information (Critical Vs. Non-critical) for submission purpose
- Experience in ensuring that accurate, adequate and appropriate data is incorporated in Module 3 so as to ensure right first submissions
- Experience in writing supporting submission documents (e.g. justifications to support post marketing changes and response (to RFI)
- Extensive knowledge of QMS, specifically change controls and risk assessments, and continuous improvements
- Capable of working to deadlines & remain calm under pressure
- Proven ability to organize and prioritize multiple tasks
- Ability to work effectively as part of a team and cross functionally
Benefits
- Competitive salary
- Flexible working environment
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