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 Valuable manufacturing practice (GMP) guidelines
Personal Qualities:
Skilled, methodical approach to work with ‘can-do’ attitude
Even tempered, positive personality, approachable with team spirit
📌 Executive, Quality Systems Complaints Mumbai (India)
🏢 Advanz Pharma
📍 India
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.