Core mission

• Lead and manage activities related to Quality Assurance

• Maintain the local Quality Management System and monitor its compliance status

• Contribute proactively as an effective leader, functioning responsibly and autonomously while working within the framework of internal and external regulatory guidelines and procedures.

Main responsibilities

• Responsible for ensuring Good Distribution Practice (GDP) is complied with for products imported and wholesaled

• Perform Quality and compliance specific tasks including but not limited to processing product complaints, review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and product recall coordination.

• Participate in the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs

• Implementing and maintaining the QMS to ensure that required processes are established and effective

• Process owner of quality systems such as, but not limited to; internal audits/self inspection, change control, management reviews, deviation management and CAPA

• Compile and update training manuals, undertake induction training and refresher training related to QMS for local staff

• Ensure quality agreements are established with 3rd parties

• Ensure 3rd parties are qualified and maintained in an approved audit status

• Ensure product samples are authorized with maintained traceability and product integrity

• Decision of disposition for trade returns and damaged products

• Authorization of any product from quarantine to approved product status

• Maintenance, analysis and reporting of Quality KPIs

• Ensure local repackaging of products is performed in accordance with specifications and required licenses

• Review all packaging artworks from a local regulatory perspective as per internal and Corporate and local SOPs in place.

• Develop and manage effective working relationships with competent authority and Galderma Global colleagues

• Foster and maintain good cross-functional working relationships with other departments; attend cross-functional meetings and represent the Affiliate where necessary

• Represent the company in the relevant committees of the professional/industry associations, if necessary
  

Technical skills - Education/Training

• Bachelor of Science Degree in Pharmacy or Life Science

• Technical skills - Work Experience:

• Minimum five years’ experience in the pharma/medical device industry, preferably acquired in Regulatory Affairs or Quality Assurance departments

• Knowledge of medical device GMP & GSP.

Technical skills - Required pre-requisites skills/experience for this position

• Good knowledge of regulated products and the country/regional regulations and governmental authorities

• Able to read, write and speak English fluently

• Thorough knowledge of the local regulatory Guidelines and Corporate Standards and applicable laws.

• Analytical skills

• Good, positive and proactive communication and the ability to foster excellent working relations with external customers including the health authorities, industry associations and internal stakeholders

• Skills such as project management, problem solving, ability to present information in easily understood format at internal and external meetings, good time management, negotiation and interpersonal skills

• Ability to work both independently or as part of a team as required

• Be proactive, motivated and a self-starter

• Be able to balance company commercial needs with achieved compliance

• Ability to think strategically and innovatively for resolution of quality issues

• Commitment to continued improvement in department processes and performance

• Strong team player, assisting others with workload peaks and the management of challenging situations

• Proactively contributes to a positive team attitude and highly productive work environment

上班地址：力宝广场