Expert - QSRC

Healthcare Businesswomen’s Association; Selangor; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading healthcare organization in Malaysia is seeking a compliance and audit manager to oversee GxP compliance activities. The role involves managing audits, ensuring adherence to quality standards, and leading cross-functional teams. Ideal candidates should have robust experience in audit management, excellent communication skills, and a track record of successful project management. Competitive compensation and opportunities for professional growth offered.

Qualifications

• Experience in managing audits and compliance.
• Ability to lead teams and projects effectively.
• Strong communication skills.

Responsibilities

• Manage GxP compliance and audit activities.
• Support site qualification and validation.
• Ensure adherence to quality manual and policies.

Skills

Audit Management

Communication Skills

Compliance Audits

Risk Management

Decision Making Skills

Job description

Overview

Job Description Summary

Manage cost effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators). Perform preparation and management of external and corporate audits and Health Authority inspections.

Job Description

Major accountabilities:

Responsibilities

• Planning and supporting PQR/APQR activities.
• Support site qualification and validation activities (planning, advising, review).
• Implementation of Quality Systems (incl. documentation management) -Supplier management activities (agreements, oversight, audit).
• Preparation/support and coordination of CAPA/follow-up - Audit and inspection preparation and support - Change control review/approval - Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc) - Ensure process quality assurance acc.
• to regulations - QP declaration review and approval - KPI trending - Ensure applications, certificate maintenance etc. to local HA
• SPOC for communication with HA, GCA / One voice / consolidated approach / synergies for all sites within same HA jurisdiction / country - Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt - Distribution of marketing samples (where applicable)

Key performance indicators

• Successful support of projects with agreed quality and delivery dates, passing of internal and external inspections.
• Meet quality and timelines for all projects - Act in accordance with Novartis standards.
• The number and severity of cGMP issues identified during internal and external audits - Year-end figures within budget; Successful coordination of departmental operational activities

Minimum Requirements

Work Experience:

• Functional Breadth.
• Collaborating across boundaries.
• Project Management.
• People Leadership.

Skills:

• Audit Management.
• Auditing.
• Communication Skills.
• Compliance Audits.
• Compliance Risk.
• Continuous Learning.
• Dealing With Ambiguity.
• Decision Making Skills.
• Gmp Procedures.
• Inspection Readiness.
• Organizational Skills.
• People Management And Leadership.
• Qa (Quality Assurance).
• Regulatory Compliance.
• Risk Management.
• Self Awareness.
• Technological Expertise.

Languages

• English.

Skills Desired

• Auditing
• Audit Management
• Communication Skills
• Compliance Audits
• Compliance Risk
• Continued Learning
• Dealing With Ambiguity
• Decision Making Skills
• Gmp Procedures
• Inspection Readiness
• Organizational Skills
• People Management and Leadership
• Qa (Quality Assurance)
• Regulatory Compliance
• Risk Management
• Self-Awareness
• Technological Expertise