Operational Quality Manager

Are you a Manufacturing Professional looking for a challenging opportunity to drive Quality Management System improvement and simplification for your local region while working with Quality Lead across the globe? If so, this could be a great position to explore.

As an Operational Quality Manager/Lead, you will be responsible for ensuring effective Regional oversight of the Haleon Quality Management System (HQS) in your local region to meet both regulatory and customer expectations. This includes harmonizing the quality standards and simplifying processes while driving both compliance and efficiency.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Authorized Person (AP) for CHQSC Kuala Lumpur and perform all task relevant to batch release process including approval of batch in MERPs, preparation of CoA, retain sample review for products manufactured or packed in CHQSC KL in accordance with regulatory and GMP requirements
• Coordinating Product Incident Management (PIRC/ Recall), Product Complaint, Periodic Product Review at site, monitor and report KPI related to OQ section in weekly and monthly basis.
• Leading in deviation management improvement as site deviation management champion and facilitate in on-line problem solving and conduct investigations together with cross functional departments as required and authorized to provide batch disposition for release upon reviewing deviation reports.
• Revise SOPs related to OQ section in accordance with Haleon Quality System (HQS) and Regulatory requirement.
• To assist site and involve in preparation of audit, external/ regulatory audit.
• To conduct site internal audit as required.
• Leading OQ oversight team to ensure shift-based oversight of facilities, equipment, and personnel to ensure compliance to procedures in real-time.
• Conduct training in GMP and Quality / GMP related SOPs.
• Other duties as assigned by the Site Quality Head from time-to-time eg: department OPEX & CAPEX
• Overseeing validation and qualifications

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s Degree in Pharmacy, Science, or an engineering discipline, OR equivalent level of knowledge, understanding and hand on experience of Good Manufacturing Practices in the pharmaceutical environment.
• Minimum 6 years of Manufacturing/Quality experience in the Pharmaceutical industry.
• Experience with the application of Quality Management Systems in manufacturing, warehousing and distribution.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Ability to work independently and prioritize workload.
• Excellent oral and written communication skills.
• Strong interpersonal skills with an ability to enable and drive change.
• Problem identification and solving skills.
• Experience of working with multi-functional teams.
• Technical knowledge and competency in manufacturing and packaging processes
• Thorough knowledge of GMP and GLP.
• Skilled at auditing and report writing.