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.

Qualified, methodical approach to work with ‘can-do’ attitude ü

2.

Even tempered, positive personality, approachable with team spirit ü

📌 Executive, Quality Systems (Deviation) (Mumbai)
🏢 AdvanzPharma
📍 Mumbai