Quality Assurance Specialist

Overview

Quality Assurance Specialist at Novartis. Manages quality aspects and projects within the area of responsibility. Ensures and supports overall GxP conformity and compliance with the Novartis Quality Management Systems.

Responsibilities

• Ensure that change requests are managed according to Novartis SOPs from receipt through to implementation and closure.
• Conduct GxP monitoring on all sections, investigate QA noncompliance, and follow up corrective actions.
• Archive relevant documentation.
• Coordinate implementation of quality systems and procedures for the Novartis Quality Manual and quality agreements.
• Ensure that all aspects of the handling and distribution of pharmaceutical products in the country comply with the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
• Ensure that a local Quality System and Standard Operating Procedures are in place for all cGMP / GDP related activities and that compliance with cGMP / GDP regulations is maintained through training and internal audits.
• Maintain current knowledge of local and international regulatory requirements and trends to provide technical support on all quality related matters.
• Establish good working relationships with Supply Chain Management (SCM), DRA and Medical departments.
• Ensure that coordinated contact is maintained with Regulatory Authorities, local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.
• Ensure that all incoming drug products are inspected prior to release to the market in accordance with current procedures, registered specifications and local / international regulations.
• Ensure that an effective Change Control process is in place.
• Manage complaints, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local procedures.
• Support or participate in NEM cases as required.
• Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt; distribution of marketing samples where applicable.

Key Performance Indicators

Local GMP / GDP Quality System in place and continuously updated as required.

GMP / GDP risks proactively identified and effectively mitigated.

The number and severity of GMP / GDP issues identified during internal and external audits.

Minimum Requirements

Work Experience :

Participating in volunteer / community projects.

Functional Breadth.

Collaborating across boundaries.

Operations Management and Execution.

Skills :

Continuous Learning.

Dealing With Ambiguity.

Good Documentation Practice.

Guideline.

Knowledge Of Capa.

Qa (Quality Assurance).

Quality Management.

Regulation.

Self Awareness.

Technological Expertise.

Languages :

English.

Seniority level

Entry level

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing

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