The Quality Manager will be responsible for the oversight and execution of quality related activities through all stages of project. Responsibilities will include leading the development and implementation of policies, procedures and protocols to control GMP activities, implementation of GMP standards and on-going compliance initiatives and regulations. The role will obviously involve interaction with our Client, internal stakeholders and external suppliers.
DUTIES & RESPONSIBILITIES:
- Serve as GMP Quality for assigned programs
- Develop and follow procedures for the oversight of quality aspects of pharmaceutical development in an outsourcing environment, including the quality aspects of process and formulation development, manufacturing, analytical testing, packaging areas
- Perform quality activities such as:
- Validation protocols,
- Report review and approval,
- Specification review and approval
- Batch record review, approval and release to ensure timely delivery of finished products to support the clinical development plan as well as commercial sales plan
- Oversee supplier quality management activities for assigned suppliers, including;
- Confirmation of compliance,
- Management/conduct of quality audits and inspection readiness activities
- Creation and management of site inspection test plans, non-conformance reports via company ACTIVE management system.
- Perform and participate in internal audits as assigned
EXPERIENCE & QUALIFICATIONS:
- Successful applicants must be able to demonstrate excellent quality experience as well as 3+ years of hands on QA/QMS experience ideally within a manufacturing or highly regulated environment
- A demonstrated ability to develop and implement procedures
- Demonstrated audit conduct and management experience
- Fluent English communications skills (written & spoken)
This vacancy is being advertised by Belcan.
