Quality Assurance Team Lead

About the Company

About the Position

Key Responsibilities

• Manage/support and lead the team in ensuring smooth manufacturing operations, in handling deviations/CAPA, change control, complaints, customer management, critical issues, recalls, etc. and that they are in full cGMP compliance to regulatory.
• Provide oversight (Review/Approval) of GMP Record/Document in ensuring compliance
• Ensuring manufacturing documentation is kept up to date.
• Review of cGMP documents to ensure company processes comply.
• Train and provide assistance to less experienced members of the QA team on quality procedures, protocols, and documentation.
• Maintain Quality Assurance documentation.
• Review, approve and communicate root cause and corrective action to stakeholders.
• Corrective and Preventive Actions (CPAs) - Record and monitor all problems arising, with the objective of identifying the root cause and resolution.
• Oversee the assessment and maintenance of quality related reports.
• Provide training sessions in policies, processes and procedure as required.
• Manage QA team members including assignment and supervision of work activities, setting of short-term objectives and monitoring performance.
• Maintain the quality management system and site in a state of inspection readiness for regulatory inspections.
• Ensure effective QMS and QA support is provided to operational functions to maintain batch release as per EU GMP requirement.
• Compile and analyse data, crafting reports, reviewing change requests and executed documentation on compliance related activities.
• Support Trackwise management of audits and inspections – including timely system entry, monitoring and follow up.
• Ensure own KPI’s, plans, targets and objectives are optimally supervised and achieved
• Implementation of continuous improvement of GMP processes.
• Support projects within the department and cross functional on the site and/or within the network.

Experience/Requirements

• Bachelor/Master degree in Science
• 3+ years of experience with some leadership experience
• Ability to oversee multiple projects simultaneously
• Experience in managing diverse relationships.
• Excellent technical writing skills
• Comfortable working in a busy, fast paced regulated manufacturing environment

Remuneration Package

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