Associate Manager, QC Operations

Summary

• Responsible for providing technical and supervisory leadership to overall QC operation, including Incoming QC (IQC), In-Process QC (IPQC), Lot Release QC (IPQC) and Outgoing QC (OQC) for Legal Manufacturer products, CM/OEM products, and TPP products.
• To ensure adequate resources planning to meet test support demands, and smooth, timely execution of the assigned routine testing activities for raw material, subassemblies, and Final Goods (FGs) release as well as to support non-routine testing activities for monitoring, validation, and engineering studies.
• Manage QC team and set quality standards to ensure that operations comply with the requirements of QMS, reference standards including ISO13485, MDR, Japan MHLW, Pharma GMP as well as other applicable regulation in the markets we serve and responsible for the overall product quality.
• Established and maintain the documented procedures for QC testing/measurement. Maintain personnel competency to achieve the valid quality decision outcome. And maintain the stability and validity of measurement equipment’s/tools for operational excellence, quality compliance and fulfil business needs on sale demands. Ensure DHR/LHR records fulfilled the standard compliance, GMP, GDP and GLP requirements correspondingly.
• Accountable for the external/internal audit, and follow up systematically in the post-audit findings by effectively implement the changes within the given period.

Roles and Responsibilities

• Provide overall supervision to ensure effective and compliance operations of IQC, IPQC, LRQC and OQC.
• Establish training plan for new joiner and maintain the training competency and proven training effectiveness of the existing personnel.
• Oversee the team of inspectors/lab support, technicians for day-to-day functions to support the on-time delivery of good quality product to the market, and review the performance of the personnel.
• Work out QC capacity plan, human and material resources needed to meet the sales demands.
• Maintain the validity of measurement equipment’s/tools through calibration and verification at the specific interval.
• Establish and apply AQL to achieve necessary statistical confidence level per the acceptable risk level of material/assemblies inspected
• Use Statistical Process Control (SPC) by applying quality tools; Prepare reports by collecting, analysing, and summarizing data; Conduct periodic review of trending to maintain stable manufacturing process and make improvement recommendations.
• Maintain and initiate the improvements QC inspection/testing procedure and test equipment to achieve maximum efficiency and cost-effectiveness.
• Strong analytical skills and judgement to interpret test data. Review and approve test reports, and lot release forms and ensure timely release of the materials, components and finished goods.
• Monitor the materials, components and finished goods quality performance, work with various process owners to investigate and resolve non-conformities or CAPA encountered and initiating correction action and preventive action (as needed) to ensure product quality
• Ensure compliance toward QMS, cGMP, and 5S for all the operational activities.
• Ensure Pharma GMP, GLP compliance on In-house API manufacturing
• Responsible for staff health and safety for QC operations, and ensure that workplace health and safety guidelines are trained and followed.
• Perform any other related duties as assigned by superior.
• Maintain QC and the laboratory in audit ready status and support site audits/inspections
• Built up a strong team work culture through effective communication and staff engagement
• Responsible for the smooth and effective QC operations to fulfil the business demand delivery through appropriate resources planning and staff competency training
• Ensure QC operational procedure/method, equipment fulfil compliance requirement and maintain good product quality

Requirements

• Minimum a Bachelor Degree in Science or Engineering related disciplines or equivalent
• At least 3-5 years of relevant work experience in QC, QA fields or equivalent, with the ability/experience to understand the principle or operation of the measurement equipment or even analytical instruments.
• Good knowledge and understanding on MDD/MDR, ISO 13485
• Knowledge or experience on risk management on ISO 14971 or pharmaceutical exposure will be added advantages
• Good experience of QA/QC and cGMP/GDP/GLP requirements
• Knowledge on Statistical Process Control (SPC) and quality management/analysis/improvement tools
• Leadership experience and peoples management skills
• Excellent interpersonal and communication skill is essential and possess positive attributes
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• High level of integrity
• Able to work under stress, prioritize, and deliver according to schedule