QA Coordinator, Compliance

Job description

Job Description

Job Purpose
The QA Compliance Coordinator establishes and manages site compliance systems to ensure that the site is in compliance with Novartis and regulatory quality compliance requirements.

Key Responsibilities
• Lead the QA compliance team to ensure that the site is in compliance with Novartis and regulatory quality compliance requirement.
• Establish and manage site compliance systems including Site Quality Council, Change Control Board, Quality Risk Management, GMP training management, audit and inspection program, KQI Cock-pit management, quality escalation program, data integrity program, QM/QD/GOP implementation pro-gram, AQWA system
• Manage site internal (e.g., GCA, self-inspection) and external (e.g., EU, FDA) audit program
• Conduct internal audit of site GMP systems and processes
• Ensure all related-CAPA is implemented and closed in a timely manner
• Ensure that Site Change Review Board (CRB) is executed and that site change control process and activities are supported
• Co- chair with Quality System & Compliance Lead the Site Quality Council (SQC)
• Prepare the monthly meetings e.g., preparation of agenda, consolidate presentations and reports. Report key site quality metrics and track the action
• Create and/or Review site compliance required risk assessments e.g., compliance alert, or any compliance risk assessment
• Coordinate implementation at the site of the relevant global Novartis Corporate Quality Manual, GOP, QD requirements on site
• Develop objectives and implement appropriate strategies for QA compliance activities.
• Coach and guide the QA compliance team to build individual associate competencies and team capabilities.
• Collaborate with the other site functions as well as across the Novartis network for QA compliance activities, benchmarking and continuous improvement.
Position Title

QA Coordinator, Compliance

Desired profile

Minimum requirements

• Masters or Degree in Natural Sciences (Biotech preferred) or related experience (sterile manufacturing)
• Minimum 8 years’ experience in pharmaceutical GMP-regulated industries (Biotech preferred) including minimum 3 years in Quality Assurance / Compliance and supervisory role
•Must have a working knowledge of FDA and ex-USA regulatory requirements as well as industry quality management tools, standard, and quality systems.
•Must have an understanding of pharmaceutical industry trends and practices.
•Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
Job Type

Full Time
Company/Legal Entity

Singapore Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd
Country

Singapore
Work Location

Singapore
Functional Area

Quality
Division

Novartis Technical Operations
Business Unit

NTO QUALITY
Employment Type

Regular
Sourcing Statement

You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.