Quality (QC & QA) Director - Pharmaceutical

Quality is the heart of everything we do at Multicare Egypt for Pharmaceutical Industries. We are installing additional production lines to join the existing one; namely the Semi-Solid and Soft Gelatin Capsule Production Lines. With such significant expansion we are searching an exceptional profile to lead both Quality Control and Quality Assurance Functions.

Vacancy:

Designation: Quality Director

Location: New Cairo

Grade: qD01/qD02

Reporting: Plant Headf

Job Purpose:

To manage all quality related activities in Multicarer's Site including both arms of QC and QA ensuring regulatory compliance. The scope covers any action that potentially impacts final product quality.

A.Essential Duties and Responsibilities:

• Provide quality oversight and guidance to ongoing laboratory investigations and deviations. Apply relevant analytical experience to solve technical problems in order to partner with the laboratories to identify root cause. Ensure that laboratory investigation reports and deviation reports are investigated, the information documented with sound scientific justification, adequate impact assessments are provided, appropriate root cause identified, meaningful correct/preventive actions proposed as established in the current procedures
• Promote the quality improvement of QC department and assure the adequacy of the relevant SOPs to cGMP
• To ensure that all required chemistry testing for utilities, raw materials, manufacturing processes and products are analyzed and approved timely in accordance with Good Manufacturing Practices (GMP), corporate, regulatory and external agency regulations.
• Plan the presence, shifts, performances and training of the QC & QA Teams to ensure meeting the demand of the production plans
• To provide guidance, support and technical expertise for QC testing and monitor results and issue corrective actions when appropriate.
• To implement reliable methods and (re)validate them.
• Ensure that analytical equipment is maintained and calibrated accurately and timely in accordance to site procedures and regulatory requirements.
• Review, revise and maintain laboratory procedures, instructions, methods to ensure compliance with regulatory, Quality Management Systems (QMS), Analytical Technical Standards (ATS) and pharmacopoeia.
• To be up-to-date with the regulations concerning biopharmaceutical QC activities.
• Assure all areas of responsibility are operated according to all safety regulations, procedures and expectations
• Conduct effective training for laboratory staff on computer systems/equipment, methods, specifications and procedures
• Review/approve various types of laboratory documentation. These documents would include (but are not limited to) laboratory investigation reports, deviation reports, analytical method validation protocols and reports, analytical method transfer protocols and reports, change control documentation, certificate of results, certificates of analysis, laboratory instrument qualification/calibration, laboratory procedures, memorandums and quality alerts according to procedure requirements
• To lead and delivery improvement initiatives/projects to improve laboratory operational efficiency and GMP performance
• Recruit, interview, and hire laboratory personnel and provides developmental opportunities for laboratory personnel
• To manage investigation of non-conformities in determining root causes and recommend and coordinate appropriate corrective actions to quality problems in conjunction with other departments
• To identify/ report/ resolve/ escalate issues promptly and appropriately
• Ensure the implementation, ongoing monitoring and reporting of Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) that drive continual improvement QC and QA organization
• Support and maintain quality systems such as laboratory investigations, deviation management, corrective and preventive actions (CAPAs), instrument qualifications and change management system
• Ensure quality systems are maintained consistent with cGMPs, Multicare's policies, site procedures and regulatory guidance. Propose, champion and implement changes to ensure continued compliance as needed
• Monitor systems to provide assurance that laboratory testing and transfer procedures, practices, process and operations are in compliance with applicable laws, rules, regulations, standards and specifications
• Review and approve SOPs and other various types of laboratory documentation according to procedure requirements.
• Create, track and approve corrective/preventative action items to help ensure they are completed with the agreed timeframes
• Review and Release Certificates of Analysis following certification of reference standards
• Support in the evaluation of resources (people, materials, and facilities) and skills to assure site compliance
• Provide oversight for administration of the training and document management systems
• Participate in and take a leadership role with respect to quality assurance management team initiatives and objectives