Executive, Quality Systems (Deviation)

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

2.

Sound working knowledge of all Microsoft Office applications

Experience & Competences:

1.

Minimum 2 years experience of working in a similar role within a pharmaceutical company.

2.

Ability to use e QMS for Quality Systems management

3.

Capable of working to deadlines & remain calm under pressure

4.

Proven ability to organize and prioritize tasks

5.

Ability to work on own initiative

6.

Ability to work effectively as part of a team

Knowledge & Skills:

1.

Excellent communication skills, both oral and written, to include senior management in third party suppliers

2.

Well, organized with logical & methodical approach to work

3.

Sound problem-solving skills

4.

Knowledge of ICH Q9, ICH Q10 and EudraLex- Volume 4 Good manufacturing practice (GMP) guidelines

Personal Qualities:

1.

Professional, methodical approach to work with can-do attitude

2.

Even tempered, positive personality, approachable with team spirit

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.