Purpose of the Role:
- Quality Management Systems (QMS) Compliance, ISO 9001:2015, GDP and GMP. Compliance to Regional Quality System.
- Managing GxP validation, CAPA, process improvement, and audits.
- Management and coordination of external audits relating to Quality Management System
- Develop plan for quality training to ensure all personnel are adequately trained to perform quality related tasks effectively
- Quality assurance activity in storage, distribution, return, destruction and labelling activities.
Expectations of the Role:
DUTIES AND RESPONSIBILITIES:
1.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.
- Review the temperature mapping protocol and report for controlled storage area.
- Perform the periodic review for GxP Computer systems.
- Perform and review the Audit trial review report for GxP Computer systems.
- 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.
- Perform any additional tasks/projects as assigned and discussed with direct manager
2.ISO, GMP and Regulatory Compliance
· Ensure compliance to ISO procedures, GMP and all regulatory requirements.
3.Communication
- Work closely with inter-department personnel to ensure quality is maintained throughout the organization
- Excellent communication and organizational skills
- Ability to work autonomously or as part of a team,
- Ability to prioritize tasks to meet required timelines,
4.Others
- Assist in quality and regulatory administrative functions when necessary
- Recommend improving productivity, quality of operations in their routine work
- Review technical procedures/manuals, identify problems and recommend solutions in the areas of quality assurance
- Participate in any adhoc projects as assigned by management from time to time
- Should be registered pharmacist and willing to provide license for ZP facility
Advantage to Have:
1.Required educational level
- Degree/ Master's in pharmacy
- Experience within the Quality Assurance in Pharmaceutical industry
- Relevant experience in quality Assurance works and preferable in Clinical Research / Supply Chain / Drug Distribution
- Minimum of 3 years’ experience in GMP environment and 2 years of Quality Assurance experience.
2.Required knowledge & skills
- Good communication skills in English
- Prior experience in logistic Industry is an advantage
- Proficient in QA procedures and familiar with relevant GMP, GSP/ GDP, ICH GCP and, preferably, GLP and ISO standards. Knowledge of international regulations an advantage.
- Experience in the Clinical Trials field will be highly regarded
- Excellent working knowledge of Microsoft applications (excel, outlook)
- SAP experience
3.Job Competencies
- Quality focus.
- Initiatives and Result-oriented
- Planning and Organizing Skills
- Attention to detail
- Can do attitude, willing to think outside the box and be proactive towards tasks
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