Senior GMP Consultant - SeerPharma (Singapore) Pte Ltd
posted 5 Aug 2008

Position is located in Singapore and candidate must be prepared to travel regionally for consulting and business meetings.

Functional Description

The Senior Consultant will assume responsibility for executing regulatory compliance consulting and training in Singapore and the Asian region to the Pharmaceutical, Medical Device and Biological Industries and Hospitals. This will include Quality Assurance, GXP (G(QC)LP, GMP, GCP) and validation consulting, training, co-ordination and leadership of projects and contracts, marketing SeerPharma services and profitability for projects.

Working relationships

The Senior Consultant will report to the Managing Director, Singapore . The Senior Consultant will be expected to extensively interact and work with SeerPharma management and support staff across the business in Asia and Australia . The Senior Consultant will be required to work within a team of consultants from Singapore and Australia and take on leadership of projects.

Key result areas

• Manage individual consulting projects within the Asian region and where required by SeerPharma
• Lecture in the training programmes with Industry Organisations and Higher Education Institutions
• Assist in developing training courses
• Execute consulting, industry training and related validation services in the following areas:
  • GXP and QA Compliance advice to all international regulations and standards including PIC/S, EU, FDA, ISO
  • Develop and Prepare Quality Assurance systems documentation
  • Conduct QA/GXP audits and GAP analysis
  • GXP, QA and Validation training at enterprise and public levels
  • Prepare validation protocols and support client validation projects
  • Prepare regulatory dossiers where required
• Mentor and coach more junior Consultants assigned for specific projects.
• Interact with Regulatory Bodies where necessary
• Actively market SeerPharma services and products and establish new contracts with clients
• Prepare quotations and invoicing for clients

Secondary Responsibilities

• Assist in the planning of business strategy, regional expansion and business growth in conjunction with the Managing Director, Singapore
• Assist in the development of the Singapore branch office quality and management systems and procedures.

Qualifications and Competencies

• A tertiary qualification in chemistry, microbiology, biochemistry, engineering or equivalent related discipline
• Ideally will have worked in a multinational company in Quality Assurance, Regulatory Affairs and or Validation
• At least 10 years experience in the pharmaceutical, medical device, biotechnology or equivalent industry in quality assurance, GMP/GLP compliance, operations or validation
• Able to prepare professional standard client reports and other documents
• Exposure to, and knowledge of, international cGMPs and Quality Assurance (PIC/S, FDA and/or EU)
• Able to work closely in a small project team

Marketing and Relationship Skills

• Ability to market SeerPharma services and products to a range of clients and senior managers such as General Managers, QA Directors, Validation Directors , Training Managers etc.
• Ability to prepare and present sound proposals to clients
• Skills in developing and maintaining client and business relationships

Management and Business Skills

• Ability to co-ordinate and direct projects under Senior Consultant control and ensure clients are satisfied with SeerPharma services
• Ability to prepare and maintain consultant records, assist in preparation of quotations and invoices
• Be prepared to travel regionally for consulting and business meetings

Interested applicants are invited to send a CV and cover letter to belinda.braggs@seerpharma.com.