The post holder will be responsible for ensuring that licensed pharmaceutical products are manufactured and tested in compliance with cGMPs specific to United States FDA, Health Canada and other country health authority regulations (when applicable). The post holder will support and monitor multiple global pharmaceutical suppliers and maintain oversight of all product quality trends and quality issues.
The PQS will function as a core member of the Quality department and ensure product quality issues are resolved and escalated to NH (NorthStar) management when required.
Review and evaluate product quality documentation for all batches to ensure compliance to NH quality standards and local GMP regulations and GMP guidance's prior to shipping and distribution to the intended commercial market as per NH Batch Acceptance procedures.
Review and assess deviations, change controls, laboratory Investigation reports and CAPA's from pharmaceutical suppliers and follow up with suppliers as needed to ensure effective understanding of the quality issue and resolution prior to batch acceptance.
Assist in ensuring Product Quality policies are conducted correctly and efficiently.
Assist in the development and/or appraisal of systems for tracking product quality data from outsourced activities.
Keep Quality Management and Quality team updated on issues and actions which impact the business.
Contribute to a culture of continuous improvement with the Product Quality team and promote and participate in process changes and improvements.
Participate and contribute to quality function and cross functional team meetings.
Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required and cross training as required to ensure quality goals and core business objectives are achieved.
Support the introduction of New Products into the NH business from suppliers.
Prepare metrics to monitor and cross-compare the quality systems of suppliers.
Ensure market and non-market complaints are processed, investigated and evaluated fully as required by NH internal systems and compliance requirements.
Review stability data and results where necessary to ensure support of shelf life for NH product on the market. Monitor temperature studies from transport activities, identify issues and follow up as appropriate.
Review process validation and annual product reviews for products from suppliers to ensure products remain in a validated state.
Assist in Quality internal and external audits as required.Revision No: 6 Date of Revision: June 2020 Revision Reason: Reference to Health Canada cGMP's for Sivem Private Label
ADDITIONAL RESPONSIBILITIES AND DUTIES
(The above statements describe the general nature and level of work being performed in this job.They are not intended to be an exhaustive list of all duties. Additional responsibilities may be assigned, as required, by management. When in conflict with the job description, the Staffing Request and Job Posting supersede the job description)
Educated to degree level, ideally B.Sc. in Chemistry, Microbiology or other scientific discipline.
3+ years pharmaceutical experience in a progressive multinational organization. Ideally the post holder will have manufacturing technical or laboratory experience.
Knowledge and Skills:
Solid understanding and knowledge of cGMP and regulatory principles in a pharmaceutical manufacturing environment.
Excellent communication skills with ability to communicate at all levels within the organization.
Ability to work independently and make decisions based on judgement and integrity.
Proven analytical skills and ability to transfer findings into report and presentation formats.
Ability to work effectively with others to accomplish goals in a challenging environment.
Excellent organisational and time management skills
PC/Equipment: MS Office; knowledge of Quality Tracking Software is desirable. Work Environment/Physical Demands: General office environment; however foreign travel may be required from time to time to
Internal Number: JR0046302
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