Quality Systems Specialist

Our MNC client is hiring They are a global leader in the discovery, development and safe manufacture of new drug therapies.

The vacancy - **Quality Systems Specialist **is an important role in the compliance and quality department.

You must be someone who is able to regularly communicate with employees/customers; must be able to exchange accurate information.

Can easily grasp instructions; attention to detail with strong writing skills.

**The Role**
- Assure Company’s compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions. Communicate all identified compliance and quality risks to supervisor.
- Perform compliance assessments of site and cross-site Quality Systems (process inspections/facility inspections/equipment and record review/computer validation activities; and/or training records) including review of client audit observations.
- Review SOPs, protocols/batch records, reports, quality and regulated records (e.g. deviations, change controls, or CAPA) involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
- Participate in the process for identifying recommendations to Operations and Quality Management for improvements in auditing of quality systems.
- Participate in the preparation of study and QA files in preparation for sponsor site visits and regulatory inspections. May participate in the support of client site visits.
- Assist in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings.
- Participate in the execution of site-wide applicable regulations or standards (ISO/GLP/GMP) training sessions, as developed and approved by senior Quality Systems team members.
- Participate in the preparation of support during regulatory inspections, as required.
- Participate in the performance of internal facility inspections at planned intervals to evaluate effective control and maintenance of site quality systems. Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.
- Perform facility and equipment records and logbook reviews.
- Where appropriate, approve customer test reports and participate in reagent release activities to support laboratory operations.
- Assist in correction of any regulatory risk areas as identified by Senior Quality Systems team members.
- Participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.
- Assist with analysis and collection of site Quality Metrics via QMS.
- Assist with preparations for Quality Management Review (QMR).
- Participate in the execution of identified process-improvement for dashboard analysis and analyze metric data for QMS.
- Participate in execution of Quality Assurance projects.
- Assist with providing basic regulatory training to operations personnel.
- Provide timely responses to Customer inquiries to support their qualification / regulatory requests.

**The Person
- **Education**:Bachelor’s degree (B.S. / BA.A.) or equivalent, preferably in a life science.
- **Experience**:Minimum of 2 years in a Quality Assurance role.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- **Others**: May require occasional domestic and/or international travel (up to 10%) for customer site visit.
- May occasionally be required to wear protective clothing and equipment.