Our client, a leading generic Pharmaceutical company currently has a requirement for an experienced Quality Operations professional to join their expanding operations. The role will be primarily responsible for quality systems and quality assurance activities, compliance with cGxP’s, in addition support release of finished product and investigations of product-related issues
PRIMARY DUTIES AND RESPONSIBILITIES:
- Comply with cGxP’s & Environmental, Health & Safety regulations.
- Maintenance of a safe, accident-free and healthy work environment.
- Comply with corporate policies and procedures.
- Support the finished product non-conformance process.
- Execute the document control system & record retention.
- Develops, implements and maintains Standard Operating Procedures.
- Ensure compliance & execute all activities to the BluePoint Laboratories Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention, risk assessments, training & CAPA.
- Training were required to support the Quality Management System.
- Measure and report key performance indicators (KPIs).
- Support the Product Review Board process for product-related issues and bring to resolution.
- Support and execute the Quality Management Review (QMR) metrics, meetings & the actions resulting from the QMR meeting.
- Execute and review product related investigations internally and collaborate with external suppliers.
- Support the field alert request and recall processes.
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
- BSc in a scientific discipline (or equivalent plus experience); minimum of five (5) years in a cGMP facility in a Quality Systems/Quality Assurance Operations role.
- Essential to have good communication and attention to detail. Experience in the Pharmaceutical industry is essential.
- Six sigma certification and experience in investigational tools is desirable but not essential.
- Ability to develop and maintain cooperative working relationships with others.
- Excellent teamwork and interpersonal skills
- Ability to handle a variety of tasks simultaneously
- Excellent problem-solving skills to evaluate quality problems and apply knowledge to identify appropriate solutions.
- Ability to apply critical thinking on review of all quality-related procedures and documents
- Excellent attention to detail
- Computer literate; Excel, Word, Document Management System, etc..
- Excellent knowledge of Quality Systems, Quality Assurance, and cGxP.
For a confidential discussion and more information on the role, please contact Josh Barnes.