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

√

K

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