QA Compliance Manager
2 weeks ago
Purpose
- Develop, manage, and monitor quality procedures, standards, and specifications for value streams in compliance with
- Manage and monitor core QA activities for value streams.
- Review and approve inprocess QA programs and activities.
- Responsible for Compliance with cGMP activities on site.
- Performance management of direct reports.
- Interpret, implement, and coordinate systems, processes, policies, and procedures contributing to the quality assurance
- Provide input into existing systems, procedures and policies that impact inprocess control activities in value stream
Financial & Resource Management
- Provide input into the functional financial plan/ budget based on operational requirements
- Ensure availability and optimal allocation of resources within the department
- Implement human resource policies
- Participate in training, coaching, and development for team members
- Develop and implement performance contracts and succession plans
- Manage conflict, disciplinary, and safety issues
- Assist with recruitment
- Review and approve Deviations and CAPA plans to address systematic issues.
- Review and approve operational changes to SOPs and processes
- Participate in Risk Assessments
- Review and update MBPRs as required
- Review and approve the process for inprocess quality management
- Governance, Risk & Compliance
- Ensure site activities comply with operating guidelines and policies for the organisation and function.
- Monitor and correct compliance with legislation, policies and procedures to impact on the effectiveness of QMS
COMPETENCIES
- Planning and organizing. Exceptional attention to detail and accuracy.
- Excellent report writing and document reviewing skills.
- Interrogate information.
- Uncompromising individual integrity and work ethic.
- Exercise interpersonal skills, communication, training and problemsolving skills to optimize team performance.
- Managing performance
- Proven leadership skills, selfdriven and motivated.
JOB SPECIFICATIONS:
- Minimum requirement BSc, BTech, Degree in Natural Sciences or Engineering or equivalent as per the National
- 5 years of related work experience in a laboratory or preferably chemical manufacturing operation.
- Pharmaceutical manufacturing experience.
- Computer proficiency in MS Office and SAP.
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