About Pharm-Olam International :
Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace.
Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further.
We offer a unique working environment with a global team culture, competitive salary and benefits package.
Responsible to make decisions and follow through on actions that maintain and improve the quality systems and operational quality within Pharm-Olam.
Responsible to support Compliance in execution of : Inspection Readiness, Case Management, Controlled Standards Management, Risk Management, and Process Improvement while fostering compliance through education and communication with all Pharm-Olam employees.
Performs duties with minimal supervision, whilst helping to improve process standards.
The incumbent will be responsible within the areas of competence listed below :
1) Creation of corrective and preventative action plans (CA / PA), tracking, identifying trends, facilitating discussion and applying expertise in investigations and effectiveness evaluations, through to closure.
2) Guiding and assisting all staff in completion of cases management within the IEQMS in a timely manor resulting in high quality responses to audit results, deviations and complaints.
3) Providing trended analysis of case data regularly, used to prioritize improvement recommendations
Inspection Readiness :
1) Planning, preparing, coordinating, hosting and agreeing responses of sponsor and regulatory inspections or audits at Pharm-Olam facilities.
2) Preparation of functions and offices in their preparation for inspection or audit.
1) Maintenance of controlled documentation system, guiding the review of SOPs and associated documents (and associated training) as elements of the Quality System for continuous improvement and ongoing compliance.
1) Maintainance of risk management schema which utilize appropriate key performance indicators (KPIs).
2) Development and Maintenance of Risk Registers, Bowtie risk assessments, and associated control effectiveness.
3) Coaching all staff in the development and use of the Bowtie risk assessment methodology
1) Coordination of quality and compliance data, working to provide demonstrable operational and financial efficiencies through Practical Process Improvement (PPI) while maintaining and reinforcing compliance.
2) Identification of problem areas based on data and trends of overall system functions.
3) Provision of guidance for all staff in the use of practical process improvement tools and methods.
Working Relationships :
or a combination of education and experience.