Job Description
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.
Job Spec
- 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.
Person Spec
- 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.