Executive , Quality Systems Complaints

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

Sound working knowledge of all Microsoft Office applications

Experience Competences:

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

Ability to use eQMS (eg. TrackWise, Veeva Vault etc.) for Quality Systems management

Capable of working to deadlines remain calm under pressure

Proven ability to organize and prioritize tasks

Ability to work on own initiative

Ability to work effectively as part of a team

Knowledge Skills:

Excellent communication skills, both oral and written, to include senior management where escalation is required.

Well organised with logical methodical approach to work

Sound problem solving skills

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

Personal Qualities:

Professional, methodical approach to work with can-do attitude

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.