Main purpose of role:
- The Quality Compliance Team within the Quality Department is responsible for ensuring Contract Manufacturing Organizations (CMOs) are provided with current Marketing Authorization information and ensuring that CMOs comply 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 within a pre-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- Quality Compliance has a cross-functional role working closely with Regulatory Affairs, Technical, Operations projects, other Quality functions and CMOs to ensure the above is achieved.
Key responsibilities (In Points):
• 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 RFls 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.
Document Number - Q-FO-1221 Version - 1.0
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Requirement Essential Desirable Qualifications:
1.Minimum Degree in Chemistry, Pharmacy or Microbiology
2.Post Graduate Qualification in relevant scientific discipline
Experience & Competences:
3.Minimum 5 years' experience of working in a similar role within a pharmaceutical industry
4.Extensive GxP knowledge across all 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 continuous improvements
10.Capable of working to deadlines & remain calm under pressure
11.Proven ability to organize and prioritize multiple tasks
12.Ability to work effectively as part of a team 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 third party suppliers
15.Sound working knowledge of all Microsoft Office applications
16.Well organized with logical & methodical approach to work
17.Sound problem-solving skills
18.Good organization & time management skills
Personal Qualities:
19.Professional, methodical approach to work with 'can-do' attitude
20.Even tempered, positive persona, approachable
21.Helpful & flexible with strong team spirit
22.Cultural leader for core values
