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.
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