EXECUTIVE, QUALITY ASSURANCE

DUTIES AND RESPONSIBILITIES:

Quality Assurance Activities

Responsible for supporting the Head of Quality in maintaining GxP License and Quality Management System (QMS) in compliance with Zuellig Pharma Regional guideline and applicable local SOPs.

Responsible for maintaining quality procedures, processes, programs, and practices, to assure the company continuous compliance with appropriate GxP standards and regulations and quality improvement.

Ensures Quality Management Systems (ISO 9001, GxP and Regional Quality System,) are established, improved and managed in support of business objectives to ensure all colleagues understand and execute their responsibilities within the quality system.

Maintain repository, prepares, reviews and updates of applicable standard work, policies, procedures, job aids and business process with relevant stakeholders.Support functional teams with the internal set up of new clinical trial studies.

Support functional teams on investigation of complaints and process deviations in timely manner and recommend appropriate corrective and preventative actions.

Maintain Corrective and Preventative Actions (CAPA) system and facilitate its activity to ensure timeliness, effectiveness and compliance of the system (e.g. Audits, Deviations, Quality Risk Management etc).

Manages QMS document control and facilitate the revision, review and approvals of procedures and other ISO, GxP documents (e. g. change control, validation).

Facilitate change control, and applicable validation requirement.

Conduct of supplier assessment and audit. Ensure supplier's performance to quality and regulatory requirement through qualification, audit, supplier quality agreement (as required) and CAPA program.

Lead / Conduct self-inspection and participate in regulatory inspections & client audits.

Support validation & calibration of temperature measuring equipment & GxP Computer systems and periodic revalidation.

Lead / Support with recall, mock recall & disaster recovery testing.Support in establishing training curriculum, GxP training plan, conduct training and maintaining training systems.

Manage and maintain databases for the Quality Management System, and prepare/assist in preparation of monthly and annual reports including quality trending reports.Keep senior and local country management appraised of major quality issues on a regular basis.

Support Quality review of incoming and outgoing shipment documentation as required.

Support batch production record review as required.Complete all training (including GxP training) as per training plan.

Participate in an on call roster as required (7 days, including public holidays for emergency shipments or temperature alarms).Support to improve quality system and process of data collection.

Performs any additional tasks/projects as assigned and discussed with direct manager. 

ISO, GMP and Regulatory Compliance

Ensure compliance to ISO procedures, GMP and all regulatory requirements.

Communication:

Work closely with inter-department personnel to ensure quality is maintained throughout the organizationExcellent communication and organisational skillsAbility to work autonomously or as part of a team,Ability to prioritize tasks to meet required timelines,

Others:

Assist in quality and regulatory administrative functions when necessaryRecommend improving productivity, quality of operations in their routine workReview technical procedures/manuals, identify problems and recommend solutions in the areas of quality assuranceParticipate in any adhoc projects as assigned by management from time to timeShould be registered pharmacist and willing to provide license for ZP facility