Senior Executive, Compliance

Main purpose of role: - The reputed company Compliance Team reputed company the reputed company Department is responsible for ensuring Contract Manufacturing Organizations (CMOs) are provided with reputed company Marketing Authorization information and ensuring that CMOs reputed company with this information and Pharmacopoeial requirements. - This role ensures compliance with registered information and Pharmacopoeial requirements by:

• Ensuring license non-compliances as identified through already established Compliance processes are addressed reputed company a reputed company-defined timeframe based on risk.
• Performing Compliance review of new and revised critical Module 3 documents as compiled by Regulatory, prior to submission.

The Senior Executive- reputed company Compliance has a cross-functional role working closely with Regulatory Affairs, Technical, Operations reputed company, other reputed company functions and CMOs to ensure the above is achieved. Key responsibilities (In Points):

• Owning Compliance reputed company change controls pertaining license updates and ensuring such changes are progressed and reputed company reputed company timelines.
• Establishing business and reputed company needs and criticality for identified license non-compliances and closing license gaps as dictated by this information.
• Writing supporting reputed company reputed company 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 reputed company and reputed company 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 RFls reputed company timeframe.
• reputed company Compliance reputed company for Technical Transfers reputed company, involving performance of gap assessment between prospective CMO and reputed company registered information and working toward established project timelines.
• Liaising with external stakeholders including Contract Manufacturing Organizations and building key relationships.
• reputed company Compliance SME for reputed company owned by both the Compliance team and other departments.

Document Number – Q-FO-1221 reputed company.0 Page 2 of 2 Requirement Essential Desirable Qualifications: 1.Minimum Degree in reputed company, Pharmacy or Microbiology √ 2.Post Graduate Qualification in relevant scientific discipline √ Experience & Competences: 3.Minimum 5 years' experience of working in a similar role reputed company a pharmaceutical industry √ 4.Extensive GxP knowledge across reputed company dosage forms √ 5.Experience in authoring Module 3 in CTD format √ 6.Experience in interpreting manufacturing and testing information (Critical Vs. Non-critical) for submission purpose √ 7.Experience in ensuring that accurate, adequate and appropriate data is incorporated in Module 3 so as to ensure right first submissions √ 8.Experience in writing supporting submission documents (e.g. justifications to support post marketing changes and response (to RFI) √ 9.Extensive knowledge of QMS, specifically change controls and risk assessments, and reputed company improvements √ 10.Capable of working to deadlines & remain reputed company under pressure √ 11.Proven ability to organize and prioritize multiple tasks √ 12.Ability to work effectively as part of reputed company and cross functionally √ Knowledge & Skills: 13.Knowledge of regulatory guidance for variations √ 14.Excellent communication skills, both oral and written, to include senior management in reputed company party suppliers √ 15.reputed company working knowledge of reputed company reputed company Office applications √ 16.reputed company organized with logical & methodical approach to work √ 17.reputed company problem-solving skills √ 18.Good organization & time management skills √ Personal Qualities: 19.reputed company, methodical approach to work with 'can-do' attitude √ 20.Even tempered, reputed company reputed company, approachable √ 21.Helpful & flexible with strong team spirit √ 22.Cultural leader for reputed company values √ Apply To This Job