Essential Job Functions
- Provide proactive and reactive guidance and support for a clinical testing company in the GCP, GMP, and occasionally the GLP environment.
- Manages other Quality staff members activities and directs their focus to relevant tasks and projects.
- Support programs and projects for QMS improvements and participate in projects as subject matter expert.
- Manages Internal Audit Program and continuously trains all staff members on quality.
- Act as the GCP, GLP, GMP and subject matter expert in writing and revising SOPs.
- Provides support in sponsors and regulatory inspections.
- Conducts targeted investigations at clinical study processes to determine root cause of significant noncompliance.
- Reviews and identifies improvements that enhance the quality and clarity of audit reports.
- Assists in formal responses to regulatory inspections and non-regulatory audits.
- Actively support business development and thought leadership responsibilities.
- Maintains relevant knowledge of both local and international regulations and GxP requirements and developments as they influence SOPs and compliance.
- Conduct studies documentation review to provide feedback for principal investigator, sponsors, CRM and company management.
- Actively support the development and delivery of general training program for employees.
- Helps Implement and Manage ISO 9001 Certification
Qualifications
- Bachelor of Science, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy) and 10 years (or combination of MS with 8 years, PhD with 5 years) of experience in Quality Department with demonstrated ability to identify, define and implement quality systems
- 4 - 5 years of experience working with Contract Manufacturers and Quality System establishment
- Solid knowledge of GxP and applicable international regulations/guidelines
- Understanding of foreign regulations, guidelines and practices for cosmetics and OTC products
- Understanding of ISO 9001 and Customer Service as a function of Quality
- Proficiency with Microsoft Office and Web applications
- Exceptional organisational skills, attention to detail and follow through
Physical Demands of the Job
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
- Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction, and having the ability to receive detailed information through oral communication, and making fine discriminations in sound.
- Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
- Hand dexterity/Repetitive Motions – for typing/tablet and phone use.
- Visual acuity – preparing and analysing data/transcribing/analysing photos – colour/details etc.
- Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- The worker is required to have close visual acuity to perform an activity such as: preparing and analysing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
Work Environment
The work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- The worker is subject to an office environment and there is climate-control, not substantially exposed to adverse environmental conditions
- The worker is subject to normal noise levels
