About this role
Main purpose of role:
- Implementation of effective and compliant Quality systems specifically for Deviations.
- To assist in Complaints, CAPAs handling and Management Review when required
- Support in basic e QMS queries and assist cross functional colleagues in progressing Deviations.
Key responsibilities (In Points):
- Execute Deviations investigations in accordance with the defined procedures ensuring that:
- Deviations are raised in the system.
- Deviation investigations are allocated and investigated by appropriate personnel / organization.
- Deviations are investigated to the required standard and that Root Cause is identified (leading to appropriate CAPA)
- Liaising with CMOs and appropriate personnel to ensure that deviations are investigated, appropriately documented with supporting evidence, and closed in a timely manner.
- Execute Complaints investigations in accordance with the defined procedure.
- Provide support for the Management Review process by collating information and preparing data, graphs, and reports.
- To assist in the investigations of Product Quality Complaints and resolutions
- To assist in following up with CAPA owners to ensure that actions are implemented in a timely manner.
- Creation of Quality related documentation (SOPs, Risk Assessments etc.)
- Report Quality Systems metrics.
- Other activities as may be required, at the discretion of management.
Requirement
Essential
Desirable
Qualifications:
1.
Minimum Honors Degree in Chemistry, Pharmacy or Microbiology
ü
2.
Sound working knowledge of all Microsoft Office applications
ü
Experience & Competences:
1.
Minimum 2 years’ experience of working in a similar role within a pharmaceutical company.
ü
2.
Ability to use e QMS for Quality Systems management
ü
3.
Capable of working to deadlines & remain calm under pressure
ü
4.
Proven ability to organize and prioritize tasks
ü
5.
Ability to work on own initiative
ü
6.
Ability to work effectively as part of a team
ü
Knowledge & Skills:
1.
Excellent communication skills, both oral and written, to include senior management in third party suppliers
ü
2.
Well, organized with logical & methodical approach to work
ü
3.
Sound problem-solving skills
ü
4.
Knowledge of ICH Q9, ICH Q10 and EudraLex- Volume 4 Good manufacturing practice (GMP) guidelines
ü
Personal Qualities:
1.
Professional, methodical approach to work with ‘can-do’ attitude
ü
2.
Even tempered, positive personality, approachable with team spirit
ü