Our global pharmaceutical client faces a busy schedule of major products launches. They wish to appoint an experienced Quality Systems Manager to support the on-going development and maintenance of the Quality Management System required for both WDA and MIA licenses. The appointee will also fulfill the role of deputy Responsible Person.
This perm OR contract based role can facilitate an immediate start.
- Support the development, implementation, and maintenance of the Quality Management System to ensure compliance to all relevant regulatory standards.
- Operation and maintenance of the Document Management system to ensure control of SOPs, records and other documents.
- Management of quality systems such as Deviation, CAPA, Change Control, Training, Complaints, Internal Audit, Vendor Management, and Risk Management to ensure compliance & escalation as appropriate.
- Establish and maintain robust document & record retention / storage process.
- Preparation & processing of quality documents & logs as required by the QMS.
- Support the vendor qualification program including initial and ongoing qualification to ensure quality oversight of GxP Vendors.
- Co-ordinate approval of suppliers, customers and associated activities such as Bona Fide checks
- Participate in supplier & internal audits as required.
- Support of data preparation for periodic review of the QMS and management review as appropriate.
- Support relevant customer complaint investigations and ensure timely closure.
- Preparation, delivery and coordination of training on GXP, QMS, SOP’s and processes.
- Act as Deputy Responsible Person.
- Be a key member of company audit team during regulatory or customer audits.
- Support the development and reporting of quality metrics.
- Partner with the global Quality department and other cross functional groups to ensure the proper application of both the corporate and Quality Management system.
- Work in close partnership with the global Quality department and other cross functional partners to meet timelines and achieve business results.
- Participation in the preparation of annual product reviews, annual reviews and other essential documents when required.
- Co-ordination of documents for QP release.
- Bachelor’s degree in chemistry, biology, pharmacy or a related discipline. An advanced degree desirable
- A minimum of 5 years-experience in a quality role in a pharma company
- Thorough understanding of quality management systems and GMP required.
- GDP experience an advantage but not essential.
- Experience working with contract manufacturers and in a virtual environment desirable.
- Strong inter-personal skills including the ability to work effectively in a global team environment and to build collaborative relationships with peers and other stakeholders.
- Highly organized with the ability to multi-task.
- Strong time management skills
- Ability to communicate effectively with all levels of management both verbally and in writing.
- Good presentation skills
- Strong experience working with electronic systems and IT platforms.