Who we are:
Our constant passion for the pursuit and achievement of excellence allows us to develop innovative treatments on five continents, as well as meet the unmet medical needs of individuals, families, and healthcare professionals.
An opportunity to make a difference in the lives of millions of people today and in the future.
General Description:
Under supervision of Exeltis Quality Director in solid line and Technical Director in dotted line and as the Person in Charge of Quality Assurance is responsible for planning, directing and monitoring the implementation of quality system I quality assurance in order to ensure the product processed in accordance with applicable procedures and meet the quality requirements that have been set.
Main Responsibilities:
- Develop quality assurance strategies and procedures and establish company's quality manual, in order to ensure compliance on every stage of the manufacture process.
- Establish good working relationships with other departments to collaborate in order to identify training needs and training plan (both carried out by the QA department and each department) to ensure the qualifications of personnel meet the quality standards that have been set.
- Plan and monitor the internal audits and self-inspections to ensure theim plementation of the quality system running well so that every activity related to the production process is in accordance with procedures and meets quality requirements.
- Analyze the results of investigations and review the deviation reports to recommend appropriate action for deviation handle and set preventive action.
- Evaluate and analyze audit findings to develop and recommend corrective and preventive actions and implementation schedules, verification of completed actions in order to ensure CAPA closed on time.
- Evaluate and authorize all procedures and documents related /impact of quality products to ensure compliance with technical or the National Agency of Drug and Food Control (NADFC/BPOM) related to the quality of finished products.
- Mentoring and coaching subordinate in order to improv-e the competence of subordinates in accordance with their respective areas of work.
- Plan and monitor the implementation of external audits (vendor audit) to ensure vendors (raw material manufacturing, packaging materials manufacturing and suppliers) meet the specifications and compliance with CPOB.
- Conduct assessment of technical complaints and make decisions and take action on the results of the assessment, unnecessary in collaboration with other departments.
- Monitor documentation of change control system implementation and approve changes to ensure all changes are evaluated, authorized, implemented and recorded in a controlled manner to mitigate potential risks and maintain compliance with regulatory requirements.
- Together with the Production and Engineering Departments responsible for the documentation of monitoring and controlling of the drug manufacturing environment to ensure compliance with CPOB requirements.
- Give approval and monitor manufacturing drugs and analyzes based on contracts.
- Conduct product quality review according to the established schedule to ensure process consistency and overall product quality.
- Determine and supervise the implementation of a record keeping system of all activities to ensure they are well documented and easily traceable.
- Establish and monitor the implementation of Personal hygiene/sanitation at site to ensure compliance with GMP requirements.
- Give consent to reprocessing after identifying corrective and preventive actions to avoid recurrence deviations..
- Authorize the determination and together with Production Department to monitoring documentation of stora9e conditions for materials and products to ensure they are maintained safely and meet GMP requirements.
- Coordinate and facilitate the conduct of audits by external parties (BPOM audit and toll in manufacturing).
- Establish 900d working relationships with the Regulatory department in order to provide the required documents.
- Prepare and controlan annual bud9et (OPEX and CAPEX) by estimating requirements and scheduling expenditures to ensure that operational costs QA department not exceed the specified budJft (meet QA financial objectives.
KPIs will be evaluated
% Right first time manufacturing
% Right first time packaging
% Lot acceptance rate reprocess/reinspect
% Lot acceptance rate reject
% Deviation overdue closure
% CAPA not Authority overdue closure
% CAPA Authority overdue closure
% Complaint over due closure
% Change control over due closure
Company core competences:
Functional Competency :
Leadership, Strategic Thinking, Decision Making, Cultivate Innovation, Drive Results, Collaborates, Instill Trust.