Job Summary 

  • Product Manager responsible for development and deployment of approved development priorities associated with Pharmaceutical programs (i.e. GMP)
  • Ensure programs fit the theme of scalable, global consistency, relevant and optimise chargeable mandays
  • Pharmaceutical Audit Execution
  • Responsible for capacity planning, building and training of operational staff
  • Act as the category champion and company ambassador for the product

Main Responsibility

Services Development (1)

  • Design checklist, audit documents, protocol and methodology as required by business line.
  • Maintain a Pharmaceutical law data bank for applicable countries in the Region
  • Maintain accreditation status of the existing Certification Program
  • Develop systems for new Audit solution programs
  • Monitor the capacity & capability of skills for new and existing services
  • Work with local BD teams to develop new business and customers

 

Technical Support to our Clients (2)

  • Review all technical documents relating to the audit services and provide comments/summaries to the operation team to implement.
  • Liaise with the clients about technical issues as needed.
  • Assist Customer Services team to handle client enquiries and feedback on new services.
  • Work with network to prepare, organize and deliver supplier seminars & workshops.

 

Quality Enhancement (3)

  • Assure the consistency of audit approach, reporting and work quality.
  • Provide technical support and guidance to local operation units within the region.
  • Perform special audits for clients attending audits, pilot programs or onsite training
  • Document SOP to drive quality execution as per KPI’s.
  • Prepare work instructions for strategic clients and pilot programs.
  • Take necessary corrective & preventative action to improve execution of new service

 

Program Governance & Training (4)

  • Enhance quality of operation unit by organizing periodic training for new services.
  • Build clients loyalty through technical support, product enhancement & improvements.
  • Conducts regular review of program work instruction to ensure its effectiveness
  • Develop, revise and upgrade product SOP’s as required.
  • Work with APAC teams to make sure the program meet internal process and criteria.

Candidate Requirements:

  • Bachelor degree or above in science/technical (e.g. manufacturing, engineering), Pharmaceutical is preferred;
  • Has a minimum of five years of GMP operational pharmaceutical experience with a minimum of three years of that experience in a quality related function. Operational experience includes those skills and competencies gained while working within a pharmaceutical GMP environment.
  • Is knowledgeable about pertinent regulatory and best-practices requirements (e.g. ICH Q7 for APIs, CFRs for USA, IPEC guidelines for excipients), of API, Excipients, Basic Chemical/Raw Material, Packaging, Chromatography Resins or GDP;
  • Certified by programs, e.g. ASQ, ISO17020, IRCA, or APIC, GMP, etc.;
  • Audit experience with at least 10 audits of relevant supplier/audit type listed above in last 12 months, including leadership of at least 5 relevant audits;
  • Good communication and interpersonal skills is a must;
  • With one year project or account management experience is preferred;
  • At least 2 years of experience on technical training or coaching experience;
  • Fluent in English speaking, good command of reading and writing;
  • Good presentation skill;
  • Have high sense of business service;
  • Able to work independently and under pressure;
  • Willing to travel occasionally ;