|Job Ref. ID:
||Head – Quality Control
||UNITED ARAB EMIRATES
||UAE (RAK head office)
||Quality Control - Head of Quality Control
||Full Time Employment (Limited Contract)
||The Head- Quality Control will organize and control the jobs for the Quality Control Administration and Quality laboratory, and coordinate all quality control activities within the company. He will support the portfolio of Quality Controls Development Programs to ensure timely execution, and will be responsible to assemble, review, and trend releases, IPC, and stability data, generating reports as necessary to support specifications and expiry settings.
The Head – Quality Control is responsible for providing operational leadership for the development, implementation and maintenance of a corporate Quality Control strategy and plan. This involves evaluating and enhancing Julphar’s total quality control programs & procedures .The goal is to achieve regulatory compliance by conceptualizing, planning, implementing, directing, and administering all activities and operations associated with Quality Control as a department.
The Head – QC is responsible for creating a standard operating procedure for overall Quality Management System and GLP in line with cGMP. He reviews all processes, practices, systems to ensure the desired specified standards are being followed. The role holder coordinates with other managers and staff to improve quality standards
The Head - QC will be overall responsible for all Quality Control functions within the Company and manage staff, testing, and product quality.
The Head QC Operations assure that the requirements related to process and product quality as well as compliance are fulfilled as stated in Julphar standards and Ministry of Health requirements and to assure that Quality Control Unit of Julphar is best in class with regard to compliance, service quality and performance criteria.
|Key responsibilities & Accountability:
• Organize, control and implement Quality Management System in all Julphar plants and technical departments
• Liaise with other departments in implementing current Good Manufacturing Practices (cGMP) complying with MOH UAE, WHO, EU and US-FDA requirements for Julphar plants
• Establish Quality Culture and awareness by the right practices and clear SOPs
• Adheres with cGMP principles and to maintain them in effective manner
• Responsible for the administrative routine in the quality control department.
• Supervises all Quality Control Managers, Deputy Managers, Assistant managers and supervisors
• Supervises the testing of intermediate, bulk and finished product (i.e. to ascertain that the GMP requirements are thoroughly followed during manufacturing).
• Responsible to coordinate management of stocks of reagents and chemicals for the quality control work in the laboratories
• Responsible to feedback the accounts department with periodical consumption of chemicals/reagents for coast accounting purpose
• Responsible to follow by literature studies the scientist development within the field of quality control
• Responsible for the release all starting materials and finished products as well as intermediate and bulk product.
• Responsible for supervising the conduction of tests and analysis, required in all QC sections (via: physical lab, chemical, instrumental lab, and microbiological lab) and arrive at decisions.
• Works out proposals for feasible investment within the quality control laboratory with the aim of increasing efficiency
• Works out annual budget for the QC department
• Cooperates with the Senior Director Operations and Product Development Director (PDL), in all matters concerning production and introduction of products
• Provides support to Quality Control in complaint investigation.
• Cooperates with QA for the GLP compliance and ensure GLP compliance in QC labs
• Responsible to coordinate review for raw materials specifications
• Prepares and supplies registration department with the required secondary reference standards, including shelf life certificates
• Keep the confidentiality and originality of all documents.
• Comply with local regulations related to HSE and Julphar policies
• To take part in the investigation and evaluation of internal & external complaints monthly basis during Quality Governance Board.
• Contribute to saving projects in order to reduce costs, improve new projects and help to complete Quality Control related projects
• Prepare department budget, follow up and realize the activities within the approved budget
• To ensure that all products produced and released by Julphar are compliant with Julphar procedures, regulations and registration documents.
• Review of Quality Manual, Site Master File and authorization of Validation Master Plans for all Julphar plants.
• Review of Technical/Quality agreements and approval of Technical Documents and SOP for all Julphar plants and departments.
• Approval of manufacturing formula (MFM) and approving facility and utility layouts of all Julphar plants.
• Responsible for preparation of QC documents for the registration of new product for the part where quality control is concerned
• Responsible for updating raw material testing specification to comply with purchase requirements.
• Responsible for preparation of analytical control documents
• Participate in customer complaints, conduct control sample analysis and conducts cross-check, evaluation and signing of raw materials purchasing specifications
• Responsible for the approval of purchase samples and suppliers for procurement of materials.
• Coordinates with the purchase department and the PDL in finding the best suitable source for starting material
• Responsible to coordinate following key function by QC lab. Regarding validation-Analysis of cleaning validation samples
• Responsible for the analysis of complaint samples and process validation samples
• Participates in group as analytical and pharmaceutical expert when required
• Conducts quality control technical staff meeting and hear/suggest feasible methods to improve efficiency and output
• Responsible to arrange recording of QC technical staff achievements from time to time
• Responsible to coordinate with maintenance to ensure analytical instruments and equipment and proper maintenance from time to time
• Responsible to defend Julphar Quality Control system in case of complaints and challenges
• Ensure that the required initial and continuing training of the department personnel is carried out and adapted according to the needs of the Organization in coordination with HR and training
• Ensure Audit readiness sessions as one of the biggest priority to drive
• Maintains staff job results by coaching, counselling, disciplining, planning and monitoring.
• Define an optimum organization structure for the function, so that resources are optimally utilized and communications can be executed in an efficient manner.
• Responsible to suggest deputation of QC technical staff for training and participation of exhibitions/conferences etc
• Responsible for all the staff in QC department for training, onboarding of staffs , managing discipline and employee morale and a healthy working atmosphere in the department
• Review and ensure that operational and administrative practices, policies and procedures across the division are being followed by all employee in the function
|| - Education
||• MS/PhD in Pharmacy or Biochemistry or Chemistry or Biological science or Biochemical Engineering
• MBA or MS in quality management is an added advantage
• QA/QC and Technical Compliance experience, Top leadership / Management roles in Pharma/Gx and/or mid-size/large biotech
|| - Experience:
||• Minimum 15+ years of total experience & 10 + years of experience in Quality Management at a senior level
• Solid track-record in Managing Quality System and handling FDA’s inspections, ability to recruit and retain Talents
• Professional training and certifications obtained in the areas of regulatory inspection, compliance with cGMPs, technical submissions and requirements for monitoring compliance within the pharmaceutical industry nationally and internationally.
• In depth knowledge of international regulatory compliance (European, USFDA, WHO)
• Practical experience in managing inspection activities, reporting on compliance, investigating technical complaints, follow up on inspection compliance status both with the pharmaceutical industries and with the governmental agencies
• Certified and recognized consultant with numerous official regulatory agencies and with several pharmaceutical manufacturers
• Lead inspections as a professional recognized inspector for inspections in Europe, North America, Japan, Asia, MENA region
• Should have handled similar role in the past for better fitment in the role
|| - Training:
||• High in Strategic Planning , people management & leadership skill the role holder is responsible for supporting multiple departments and stakeholders.
• In terms of competency you are highly result oriented with strong sense of accountability & ownership.
• The Head Quality Control Operations is a Dynamic Leader with strong aptitude , master of technical knowledge and very strong adherence to Compliance
• Having an Analytical mind with ability to think diversely and understand the big picture of the Organization and its core strategies to transform the Quality Culture of Julphar
• You have excellent Technical Acumen and Strategic Planning skills for diversified Project Management experience coupled with strong influencing skills.
• Strong communication, interpersonal, presentation and project management skills required
• Must have a solution centric mind to understand issues and solve them within a stipulated time frame, should posses decision making skill for smooth functioning
• Possess the ability to develop and maintain an effective working relationship with internal and external sections, function as team player and comply with company policies.
• Demonstrated experience in providing critical input to senior and corporate management