Head – Quality Control

Job Title: Head - Quality Control Division: QUALITY Country: UNITED ARAB
EMIRATES Work Location: UAE (RAK head office) Job Type: Quality Control - Head
of Quality Control Employment Type: Full Time Employment (Limited Contract)
Job Description:* * Purpose: 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: Business Leadership • 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 Operational Leadership • 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 People Leadership • 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 Qualifications: - 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: Key Competencies: • 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 Technical Competencies: