Responsibilities will include but not limited to:

 

  • Manage and oversee ISO 9001 and ISO 13485 Quality Management Systems

  • Manage and monitor all sites GDP (Good Distribution Practice), GDPMDS (Good Distribution Practice for Medical Devices), GMP (Good Manufacturing Practice for Assembles of Medicinal Products), customer requirements and any related standards, technical guidance and/or regulations requirements

  • Organize, plan, monitor and maintain the Regional Management Review activities in order to meet company objectives and to comply with ISO 9001, ISO 13485 and GDP, GDPMDS and GMP regulations and requirements

  • Involve in overseeing the individual site QA Manager on Management Review activities, Internal Auditing, all relevant and related activities to maintain and comply with ISO 9001, ISO 13485 and GDP, GDPMDS, GMP, local country regulations and customer requirements

  • Organize, plan, implement, monitor, control and maintain the Internal Auditing processes and follow up activities for Healthcare in order to ensure the implementation of company documented QMS

  • Manage, monitor, control and maintain the CAPA processes and activities

  • Manage and monitor Document Control Centre activities in order to maintain company documentation security, change control, requisition, distribution and control

  • Conduct, review and maintain Risk Management Assessment based on ISO 14971 requirement

  • Improve and update from time to time of PowerPoint file format Training Materials for ISO 9001, ISO 13485, GDP (Good Distribution Practice), GDPMDS (Good Distribution Practice for Medical Devices), GMP (Good Manufacturing Practice for Assembles of Medicinal Products), customer requirements and any related standards, technical guidance and/or regulations requirements also Auditing Technical requirements in order to train new staff or update of current staff of the above standards and regulations requirements

  • Conduct Internal Qualification Training program for ISO 9001, ISO 13485, GDP (Good Distribution Practice), GDPMDS (Good Distribution Practice for Medical Devices), GMP (Good Manufacturing Practice for Assembles of Medicinal Products), customer requirements and any related standards, technical guidance and/or regulations requirements also Auditing Technical requirements in order to train new staff or update of current staff of the above standards and regulations requirements

  • Monitor, update and maintain the change of National and International Standards, Regulations and Technical Guides Requirements in order to prevent any cancellation or suspension of our QMS Certification

  • Implement, monitor, control and maintain Global Medical Device Adverse Event Reporting and Product Recall processes and activities in order to ensure the compliance with ISO 9001, ISO 13485, Regional and Local FDA regulations and Compliance Authority requirements

  • Ad-hoc duties when assigned by superior

  • Responsibility & authority of this designation/position are linked to and in accordance with relevant and associated SOPs

 

       SKILLS ESSENTIAL TO THE JOB

       Technical (Doing skills – job related knowledge, policies, procedures, techniques)

  • Must have strong knowledge of cGxP (such as Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), Good Storage Practice (GSP), Good Warehouse Practice (GWP) for Australia, Good Supply Practice (GSP) for China) and Quality Management Systems Requirements (such as ISO 9001 and ISO 13485)

  • Strong knowledge on Change Control, CAPA, Statistical Process Control, Training, Warehouse Quality requirements, Distribution and Manufacturing Process

  • Proficient in MS Office applications (Excel, Words, PowerPoint, outlook, project, Visio and etc) is a must.

  • Familiarity with Adobe Acrobat and Photoshop is desirable

  • Perform QMS audits at selected sites based on the company certification program

  • Hands-on, independent and self-motivated. Ability to lead, influence and work within cross-functional team environments

 

       Business (Understanding of business concepts, knowledge of the organisation, profitability)

  • Communication style should be diplomatic and direct, but not confrontational

  • Must be able to articulate clear, tangible objectives for the organization, negotiate agreements where each party benefits, and can deliver an honest assessment of the level of achievement of those goals

  • Must work well in a collaborative team environment


 

       Human Relations (People skills in servicing, influencing, developing and leading others)

  • Pleasant personality, with good technical written ability and verbal communication in English and Mandarin

  • High level interpersonal and leadership skills with capability to influence, coach, and partner across multiple levels and locations of the company

  • Independent, reliable and aggressive in project management and time management

       ESSENTIAL PERSONAL ATTRIBUTES (Demonstrated in previous roles and the individual’s career track  

       record)

  • Flexible and adaptable to changes

  • Sense of urgency

  • Organized, accurate and detail-oriented

  • Quick learner

  • Good attitude

  • Honesty and integrity

 

       QUALIFICATIONS REQUIRED

       Tertiary:   

  • Bachelor degree preferably in science or biological or pharmaceutical manufacturing or other appropriate equivalent education. Pharmacist with Singapore Pharmacy Council (SPC), preferable

  • QMS Professional Certificate

  • Registered/Certified QMS Lead Auditor or QMS Auditor or QMS Internal Auditor or other appropriate equivalent

  • Min 5 years’ experience in Quality Management Systems

  • Min 2 years’ experience in a pharmaceutical GMP-regulated and/or medical devices industries

 

       Licences:

           

  • Pharmacist with Singapore Pharmacy Council (SPC) is preferred

 

       Other:     

  

  • Experience in managing warehouse and Distribution Centre is preferred

  • Experience in GDP (Good Distribution Practice), GDPMDS (Good Distribution Practice for Medical Devices), GMP (Good Manufacturing Practice for Assembles of Medicinal Products), ISO 13485 environment

VP, regional qms

Contact

Inmind Solutions Pte. Ltd.

7 Temasek Boulevard

Level 32, Suntec Tower 1

Singapore 038987

​​

Tel : 65 98636384

Email : Corporate@inmindsolutions.com

Website : www.inmindsolutions.com

Licence No : 17S8822

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