Executive, Quality Systems (Deviation)
Date: 11 Sept 2026
Location: Mumbai, India
Company: AdvanzPharma
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 |
|