Introduction:
A key aspect of the role will be to assist in the day-to-day management of the Process and Quality Management System and to support to operations and ensure that the organization is compliant with SOPs and regulations.
Key Responsibilities:
- To assist in the development and maintenance of the Quality and Compliance System.
- To provide quality support to operations and analytical projects including review of related SOPs.
- Actively participate in and promote Quality Compliance activities
- Taking responsibility for quality aspects of the program, communication of these to the Operations Team and communication of any quality issues to Line Manager.
- Participate in quality investigations and ensure that effective CAPA actions are implemented.
- Review and approve protocols and reports such as generated for stability studies and analytical method validation / transfers.
- Where required, write, approve or authorize SOPs as required. Review QA SOPs as required to ensure their continual effectiveness and compliance with the standard principle.
- Develop and deliver training on Quality topics i.e. SOPs and Quality System as required to colleagues throughout as directed by Line Manager.
- Conduct internal audits and QA walkthroughs in order to verify compliance with the process and procedures. Ensure that audit findings are documented and corrective actions are agreed, documented and implemented in a timely manner.
- Bring the outcome of continuous improvement quality activities such as internal audits, complaints, quality incidents and deviation investigation to the attention of Managers and agree effective preventative actions.
- Participate and assist in external audits by customers and Regulatory Authorities as required.
- Bring any regulatory updates of guidelines or regulations to the attention of the relevant department and QA management to ensure compliance is maintained.
Key Experience and Qualifications:
- Previous working experience as compliance manager for 2 years minimum
- Should have a depth knowledge of GDPR and PCIDSS required
- Knowledge and understanding of the industry’s regulations and best practices
- Hands-on experience with a variety of reporting operations and procedures
- Good organizational and time-management skills
- Ability to multi-task
- Strong interpersonal and communication skills
- Critical-thinker and problem-solver
Apply now by sending your CV to: Kosovo.hiring@fusionbposervices.com with the job position as a subject.
