Job Description

Job Purpose:

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

Key Responsibilities :

• Establishes, implements, and maintains the Quality Systems for fulfilling the requirements of cGMP and other applicable standards.
• Sets the quality strategy and ensures its clear communication to all employees.
• Follows up quality assurance, quality control and R&D managers objectives and support them when required.
• Presents the annual budget of QA, QC and R&D departments.
• Authorizes policies, SOPs, protocols and other GMP related documentation.
• Sets regular meetings with QA/QC/R&D managers to review the departments progress.
• Monitors performance (in relevant areas) according to agreed standards and takes necessary action to communicate/advise/assist according to performance levels.
• Develop quality policy & standards.
• Ensure adequacy, maintenance, and continuous improvement of management systems.
• Ensure pharmaceutical products are designed and developed in accordance with the requirements of GMP and other associated codes such as those of good laboratory practice (GLP).
• Ensures quality operations of the organization are effectively and efficiently coordinated.
• Ensures compliance with legislative and regulatory bodies according to GMP requirements.
• Ensure responsibilities are clearly specified in department job descriptions.
• Promote the quality improvement of QC department and assure the adequacy of the relevant SOPs to GMP
• To ensure that all required testing for utilities, raw materials, manufacturing processes and products are analysed 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, company 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 following 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

Authorities:

• Monitor of Quality KPIs and targets.
• Set departments objectives, plans and needed training,
• Authorize dispensing / receipt of raw & packaging materials from warehouse to delivery of packed finished products to warehouse.
• Tracking quality schedules and cost adjustments to ensure everything runs smoothly.
• Responsible for the technical management, supervision, and control of industrial production processes.
• Approve staff annual leave.
• Responsible for allocating labor resources, tracking production schedules and cost adjustments to ensure everything runs smoothly.
• Responsible for the technical management, supervision, and control of processes.

Required Qualifications:

• Minimal 15-20 years experience working in a leading Quality Assurance and Quality Control roles and leadership.
• M.S. Degree or higher in Pharmacy or Chemistry is a definite plus
• Bachelor of pharmacy
• Drive for results: the drive to put energy into achieving results and take actions to exceed goals
• Clear and influential communication skills with the ability to work effectively with both medical and commercial stakeholders
• Planning and prioritizing: ability to identify needs to be done and to develop an appropriate action plan in order to accomplish an objective and to monitor progress against it
• Able to cope with stress and change
• Teamwork and co-operation: the willingness to work co-operatively and supportively with your colleagues. Developing positive, open working relationships in order to solve problems and to achieve business goals
• Proactive approach and strong critical thinking skills
• Strong collaboration, relationship management, and interpersonal skills
• Excellent written and verbal communication
• Nice-to-Have
• Global cGMP Regulatory Agency requirements.
• Knowledge in HSA, DEA, OSHA, ICH guidance and EPA regulations applicable to the pharmaceutical industry