Senior Executive, Compliance
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Job Description
Senior Executive in Quality Compliance ensuring Contract Manufacturing Organizations meet pharmaceutical standards and best practices. Collaborating with regulatory bodies to uphold compliance and quality assurance processes.
Responsibilities:
- 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.
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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