About this role
Main purpose of role:
- Implementation of effective and compliant Quality systems specifically for Complaints and CAPAs.
- To assist in Recalls and Deviations when required.
Key responsibilities :
- Execute Complaints investigations in accordance with the defined procedures ensuring that:
- Complaints are raised in the system.
- Complaints are investigated to the required standard and that root cause is identified (leading to appropriate CAPA)
- Complaint’s resolution is appropriately documented with supporting evidence.
- Liaising with CMOs and relevant stakeholders to ensure that complaints are investigated, resolved and closed in a timely manner.
- Interact with complaints reporter in the course of investigations and communicate the outcome of investigations accordingly.
- Follow up with CAPA owners to ensure that actions are implemented in a timely manner
- To assist in executing Recalls as required
- To assist in investigation of deviations when required
- Creation of Quality related documentation (SOPs, Risk Assessments etc.)
- Carry out internal audits as required
- Report Quality Systems metrics.
- Other activities as may be required, at the discretion of management.
Requirement
Essential
Desirable
Qualifications:
Minimum Honors Degree in Chemistry, Pharmacy or Microbiology
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Sound working knowledge of all Microsoft Office applications
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Experience & Competences:
Minimum 2 years’ experience of working in a similar role within a pharmaceutical company.
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Ability to use eQMS (eg. TrackWise, Veeva Vault etc.) for Quality Systems management
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Capable of working to deadlines & remain calm under pressure
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Proven ability to organize and prioritize tasks
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Ability to work on own initiative
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Ability to work effectively as part of a team
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Knowledge & Skills:
Excellent communication skills, both oral and written, to include senior management where escalation is required.
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Well organised with logical & methodical approach to work
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Sound problem solving skills
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Knowledge of ICH Q9, ICH Q10 and Eudralex- Volume 4 Good manufacturing practice (GMP) guidelines
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Personal Qualities:
Professional, methodical approach to work with ‘can-do’ attitude
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Even tempered, positive personality, approachable with team spirit
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