Executive, Quality Systems (Deviation)

Advanz Pharma Corp; Mumbai; On-site; INR 500,000 - 700,000; Full time

Job summary

Advanz Pharma Corp in Mumbai is seeking a Quality Systems professional to manage Deviations investigations, ensure proper documentation, and drive timely closure in line with CAPA.

The role supports complaints investigations, Management Review data, and creation of SOPs and quality records, requiring good problem solving, teamwork, and knowledge of ICH Q9, ICH Q10 and GMP guidelines.

Qualifications

• Minimum Honors Degree in Chemistry, Pharmacy or Microbiology.
• Sound working knowledge of Microsoft Office applications.

Responsibilities

• Execute Deviations investigations in accordance with the defined procedures.
• Deviations are raised in the system.
• Deviation investigations are allocated and investigated by appropriate personnel / organization.
• Deviations are investigated to the required standard and Root Cause identified (leading to CAPA).
• Liaising with CMOs and appropriate personnel to ensure deviations are investigated, documented with evidence, and closed timely.
• Execute Complaints investigations in accordance with the defined procedure.
• Support Management Review process by collating information and preparing data, graphs, and reports.
• Assist in investigations of Product Quality Complaints and resolutions.
• Assist in following up with CAPA owners to ensure actions are implemented on time.
• Creation of Quality related documentation (SOPs, Risk Assessments etc.).
• Report Quality Systems metrics.
• Other activities as may be required, at management discretion.

Skills

Excellent communication

Organized and methodical

Problem solving

Teamwork

Can-do attitude

Education

Honors Degree in Chemistry, Pharmacy or Microbiology

Tools

Microsoft Office

Job description

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

• 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.

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