Head - Manufacturing science & technology.

Job Title: Head - Manufacturing science & technology. Division: QUALITY
ASSURANCE Country: UNITED ARAB EMIRATES Work Location: UAE (RAK head office)
Job Type: Manager Employment Type: Full Time Employment (Limited Contract)
Job Description:* * Purpose: A) QA oversight for product life cycle
starting from research and development stage, regulatory affairs, vendor
management, process validation, APQR "continuous process verification",
product remediation in addition to sterilization validation, cleaning
validation and transport validation. B) QA oversight for facilities, machine
and utility life cycle starting from user requirement specification, offers
technical evaluation, performing FAT, SAT and the qualification/validation,
review of maintenance and calibration activities in addition to engineering
oversight and computerized system validation. C) Technical training: planning
and execution for employees in GxP areas. Key responsibilities &
Accountability: Main Responsibilities: o Approval of MS&T documents. (I.e.
Protocols, reports etc.) o Review of MS&T related SOPs. o Handling of EQMS
activities like change controls, deviations investigation, CAPA & Audit
Management. Providing the technical inputs related to MS&T as HOD role. o
Impart training to MS&T members continuously. o Participate in GMP audits and
Health Authorities inspections. o Review and provide support for regulatory
submissions as needed. o Coordination with project management teams. o
Responsible for Product life cycle and Facilities, Machineries, Equipment Life
cycle - Issuing Validation/Qualification Master plan - Coordinating with
different departments & external agencies to ensure the validation objectives
are achieved. A) Product life cycle: o Review of R&D products design, SPECS of
materials, choice of primary packaging materials, formulation, R&D trials
batches, R&D stability, Finished Product specifications. o Scale and Trial
batches in cGMP areas, Process validation batches, Stability batches of
commercial batches, ongoing batches. o Follow up and investigation any product
issues like: complaints, OOS, CAPAs, Remediation, … o Review of Analytical
methods developments, analytical method validation, verification and FPSs &
STMs o To provide the support for the introduction of new Products and
technology transfer from R&D sites, and CMO sites to Production sites. o
Vendor management activities o Review of annual product quality review. o
Process Validation, including media fill study review, Holding time study
documents. o Shipping or transport validation documents o Cleaning Validation
End to End: Protocols, Worst case selection (Initial cleaning validation,
cleaning verification, Dirty Equipment hold time studies, Clean Equipment hold
times), the review of cleaning & Sterilization procedures in the manufacturing
process of Non- sterile, sterile & Biotech areas. B) Facilities, Machineries,
Equipment Life cycle: o Reviewing all Facilities, machineries Equipment
qualification life cycle: URS, DQ, FAT, SAT, IQ, OQ, PQ o Layout review and
design approval for facilities and premises o Utilities: Utilities design,
layout and qualification o Calibration system review, QA oversight &
Calibration master plan approval. o New projects End to End Oversite from
design, engineering details, Procurements, IQ, OQ, PQ. o Engineering Oversight
activities: Utilities, Machineries, Corrective & PM maintenance, Spare parts
management. o Review of Computerized system related Validation documents. C)
Technical training: o Supervision of technical training activities. o Review
of technical training plans and training materials. o Lead and provide
training programs in different GxP topics o Support in annual technical
training budget. o Lead academic training programs. Additional KRAs ( Do
review and include if applicable) • Organize, control and implement the MS&T
concept and integrate the related functions across all Julphar plants and
Technical departments. • Liase with R&D, Supply chain, Quality and
Manufacturing departments in implementing current Good Manufacturing Practices
(cGMP) complying with National and International Health Authorities
requirements for Julphar plants. • Responsible for the successful transfer of
processes into production. Ensure process scalability and manufacturability.
In addition, the incumbent will coordinate all process relevant major
deviations and process adaptations and will be responsible for continuous
improvement of the manufacturing processes. • Responsible for trouble-
shooting/remediating and process/product optimization of Existing Formulations
for quality improvement and process optimization. • Responsible process
validation, protocols and report writings, cleaning validation, and equipment
qualification • Ensure to collaborate & work closely with both R&D Teams and
Manufacturing sites to enable the successful on-time product launches. •
Provides Techncial Support in the evaluation, remediation and optimization of
products and processes using statistical tools to ensure safety, quality,
delivery and cost standards. Qualifications: - Education • Education: MS in
Science/ Engineering / Pharmacy Degree is required. - Experience: • At least
‎14+ years' of relevant strategic and tactical leadership experience in the
process and technology development for issues that impact manufacturing
operations in the pharmaceutical industry, including managerial experience and
diverse pharmaceutical experience with different dosage forms. • Technical
Leadership experience with diverse teams at a high level is strongly
preferred. • Advanced knowledge in pharmaceutical production and packaging
processes and technologies, experience in product formulation and performance;
working experience with process technologies manufactured at the site •
Knowledge of regulatory, safety, quality, validation and documentation
requirements for product development, commercial production and site transfers
• High on Business Acumen and overall understanding of the big picture for his
function and the department - Training: Key Competencies: • In terms of
competency, you are highly result oriented with strong sense of accountability
& ownership. • Excellent verbal & written communication skill to convey
meaningful insights & information to all key stakeholders • High on conflict
resolution, negotiation & collaboration skill to lead, navigate& support
cross-functional projects • High on organizational skill with strong ability
to understand new issues quickly with a proper root cause analysis, recommend
timely decisions based on facts and business needs • Strong leadership skill
in terms of change management, new initiatives and implementation skill •
Change agile, being able to embrace and deliver change, role model continuous
improvement mindset • Strong leadership skill and team development
capabilities. • Maintains a high standard of presentation, personal integrity,
and stakeholders' support. Technical Competencies: