Executive, Quality Systems Complaints

Advanz Pharma Corp; Mumbai; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Advanz Pharma Corp in Mumbai seeks a Quality Assurance professional to lead complaints investigations, CAPA and change controls in a GMP environment.

You will manage investigations, ensure documentation, coordinate with CMOs, support recalls and deviations, and contribute to SOPs and risk assessments.

The ideal candidate has 2+ years pharma QA experience, an honors degree in chemistry/pharmacy/microbiology, and strong MS Office and eQMS skills.

Qualifications

• Minimum 2 years’ experience in a similar QA role within a pharmaceutical company.
• Knowledge of eQMS systems (TrackWise, Veeva Vault).
• Honors degree in Chemistry, Pharmacy or Microbiology.

Responsibilities

• Execute complaints investigations per procedures and document root cause and CAPA.
• Raise and track complaints in the system; ensure timely closure.
• Liaise with CMOs and stakeholders to investigate and close complaints.
• Assist in recalls, deviations, and CAPA actions.
• Create quality docs (SOPs, risk assessments).
• Carry out internal quality audits and report metrics.
• Other duties as assigned by management.

Skills

Communication

Organizational skills

Teamwork

Deadline-driven

Initiative

Calm under pressure

Education

Honors degree in Chemistry/Pharmacy/Microbiology

Tools

TrackWise

Veeva Vault

eQMS

MS Office

Job description

Select how often (in days) to receive an alert:

• 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

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