PharmEng Technology is looking for a skilled, bilingual , individual who is certified in Project Management and can perform duties for Computer Systems Validation and Process Validation in China.
The individual will be performing:
- DCS validation
- Process Validation based on FDA latest process validation guidelines
- CQV Project Manager for new and existing pharmaceutcial facilities
- Computerized System Validation training
- Proficient in Validation and Qualification aspects of systems. If required, creates and documents Validation Plan, Quality Plan, IQ Report, OQ Report, and Validation Summary Reports.
- Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements
- Conduct Quality reviews to evaluate if processes and deliverables fulfill the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement
- Follow up resolution of identified quality exposures and escalation to line management if critical situations are not resolved in due course
- Contribute to business decisions in the decisions in the definition and assessment of IT requirements
- Support the development and delivery of training in quality matters.
- Drive and facilitate the create of relevant of system SOPs.
- Prepare and follow internal authority inspections.
- Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality deliverables.
- Coordination documentation, testing and change management activities to ensure compliance with business and regulatory needs.
- Develop PQM resources for projects and services and monitor their performance to ensure adherence with agreed quality systems.
- Forecast demand and plan for IT PQM related to projects, provide task estimating and ICE roadmap to PMs, monitor and manage project risk and compliance
- Ownership IT CAPA and CCR Process for the responsible functional areas.
- Excellent written and spoken English and Chinese
- Bachelor's of Science and a minimum of 5+ years experience in IT in pharmaceutical industry with expert knowledge of current regulations
- Ability to interact with all levels of the organization
- Influence and leadership capability, and credibility within the business
- Strong organization skills
- Strong written and verbal communication skills
PharmEng Technology is an international full service consulting firm that services pharmaceutical, biotechnology, medical device, nutraceutical, heath care and chemical sectors. PharmEng Technology has a proven track record of excellence which ensures all of client needs and governing regulatory expectations are met and exceeded.
As a fast pace fast growing consulting firm we are always looking for qualified scientists and engineers with the ability to create and communicate innovative and cost effective solutions to clients. This is a great opportunity to obtain a challenging career that enables you to work closely with major international clients and travel the world!
We currently have projects all over the world in Canada, USA, Europe and Asia.
Only successful candidates will be contacted.