Job Scope:
1. Investigation and identifying the right root cause
2. Provide analytical and technical skills to maintain company quality services and products
3. Manages and supervise quality control laboratory activities
4. Supervision and leading staff
4. Ensure robust testing procedures and outputs and identifying mistakes or non-conformity issues.
Duties & Responsibilities:
- Develops procedures by understanding customer requirements in order to have an effective quality control.
- Ensure material and product specifications are in-place for supplier and monitoring compliances.
- Collaborated with the Quality Assurance personnel for the implementation of systems, procedures and standards of operation to comply with company standards and local regulations.
- Leads the establishments and implementation of procedures for sampling, recording and reporting data.
- Supervises and guides all laboratory personnel to ensures quality in the process by which products are manufactured.
- Final approver for all GxP documents.
- Designated/alternate authorized person for batch release.
- Appraises customer’s requirements and ensure satisfaction
- Facilitate proactive solutions by collecting and analyzing quality data
- Review and ensure all standards and policies are current
- Keep records of quality reports, statistical reviews and relevant documentation
- Make sure that Out of Specifications are investigated and resolved.
- Ensure appropriate actions are taken in case of willful or negligent GMP violations up to and escalating to responsible management for any necessary disciplinary action.
- Ensure all legal standards are met to maintain certifications of the laboratory.
- Ensure appropriate and timely escalation for quality related matters.
- Assess the conclusions of periodic review of process performance, product quality and the Quality Management System.
- Monitor effectiveness of quality systems, including performance of GMP and internal audits, metrics monitoring and participation in management reviews.
- Lead/Initiates/participates in any process improvements aimed at improving efficiency and savings
- Ensure appropriate interface with authorities for any GxP related activities.
- Decision on withholding products from distribution if needed, for resolution of quality or compliance issues or mandate market actions, up to and including recommendation for recall of product, following the relevant procedures.
- Escalation of any issues due to inadequate resources (personnel, budgetary, etc) to perform quality oversight or duties.
- Works collaboratively with other department for completion of investigation through root-cause analysis pertinent to product/customer complaint and other related non-conformities identified within the process in coordination with the department head.
- Prepares and submits departmental monthly/quarterly KPI and other report on a timely basis
- Lead and representative of Quality control for all regulatory and client audits and prepares necessary aids for external audits.
- Facilitate the Quality Council Meetings and is responsible for the oversight of product quality and GMP compliance for all products manufactured or distributed from the site.
