He / she will also support the development of GMP training packages and delivery of training. Under the direction of the reporting manager, continuously improve QA and Compliance systems, strengthen quality awareness and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Company and external Health Authority inspections.
The QA Specialist is reporting to Quality Affairs Director.
- Document approval (procedures, Master Batch Record, specifications, …)
- Review and approval of batch records and associated documentation
- Product release
- Approval of deviation and support to related investigations
- Provide Quality support for investigation of OOS , approve disposition decision
- Operate the change control system
- Operate the CAPA system
- Review / approval of validation protocol / report
- Work with relevant departments to ensure timely closure of quality actions / findings
- Actively contribute to continuous improvement initiatives.
- Perform inspections/internal audits and provide quality oversight for the inspection/ audit program
- Collaborate to supplier qualification
- Collaborate with operations to resolve compliance matters
- Internal Contacts / Contacts internes: All functions
- External Contacts / Contacts externes: External auditors, Customers, Suppliers
Key Competencies Necessary to Effectively Perform this Job
- Master degree Sciences
- 8 years with 3 years in a QA role
Specific skills required:
- Very good knowledge of cGMP in a regulated environment
- Knowledge of quality systems
- Excellent accuracy and attention to detail
- Excellent interpersonal skills
- Working knowledge of computer packages
- Strong problems solving skills, issue resolution and root cause analysis
- Auditing experience, auditor certification is an asset
- Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment.
- Able to work autonomously
- Language: English, French