Title:  Lead-MSAT (Validation)

gulfpharma Nunavut, Canada
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Title:  Lead-MSAT (Validation)

Detailed Job Description:

  • Lead MS&T activities supporting commercial manufacturing, technology transfer, and site readiness.
  • Act as the technical bridge between R&D, Technology Transfer, Production, Quality, and Engineering.
  • Prepare, review, approve, archive, retrieve, and distribute validation documents.
  • Ensure compliance with GMP documentation and data integrity requirements.
  • Maintain validation master plans and validation schedules.
  • Ensure robust scientific understanding and control of manufacturing processes across the product lifecycle.
  • Support in writing the URS (user requirement specifications) for Project activities, ensuring all assets has URSs before entering the Purchasing Cycle
  • Follow-up with procurement and CAPEX manager
  • Support in preparation the technical evaluation of quotations from different vendors
  • Co-ordinate with procurement, MS&T, QA in RAK site for any similar equipment procurement
  • Lead and execute the validation lifecycle using the V‑Model approach (URS, FAT, SAT, IQ, OQ, PQ, re‑qualification).
  • Ensure all critical utilities (PW, WFI, HVAC, compressed gases, nitrogen) remain in a validated state.
  • Ensure cleanroom qualification activities comply with ISO‑14644 requirements.
  • Review and approve validation protocols, reports, and risk assessments.
  • Lead or support investigations related to process deviations, OOS, OOT, and atypical results.
  • Perform root cause analysis using scientific and statistical tools.
  • Propose technically sound CAPAs and process improvements.
  • Support batch disposition decisions from a technical perspective.
  • Partner in FAT, SAT, DQ, IQ, OQ, PQ for equipment, CSV, systems (Water, utilities, HVAC, electricity, Thermal mapping).
  • Lead process validation activities for new and existing products.
  • Execute and oversee cleaning validation, sterilization validation, and transport validation.
  • Lead aseptic process simulation (media fills) and gowning qualification programs.
  • Support visual inspection qualification activities where applicable.

 

Core Competency:

  • In terms of competency, you are highly result-oriented with an intense sense of accountability & ownership.
  • High compliance adherence, having strong diligence, initiative-taking, and flexibility.
  • Excellent communication, interpersonal, and collaboration skills.
  • Must be able to manage tasks, plan workload effectively, prioritize, and easily adapt to changing situations.
  • Contribute to EHS activities, audits, and continual improvement initiatives.

 

Qualification/Functional Knowledge:

  • Bachelor’s degree in pharmacy, Chemical Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering, or related scientific discipline
    (master’s degree in pharmacy / engineering is an advantage)

  • Minimum 6–10 years of experience in pharmaceutical manufacturing within GMP‑regulated environments, with extensive hands‑on experience in qualification and validation activities

  • Strong and practical knowledge of:

  • cGMP, SFDA, WHO, EU GMP, and ICH guidelines

  • Qualification and validation lifecycle using the V‑Model approach

  • GMP documentation practices and regulatory inspection expectations

  • Proven experience in validation of:

    1. Manufacturing equipment and production lines
    2. Critical utilities (PW, WFI, HVAC, compressed gases, nitrogen)
    3. Cleanrooms in compliance with ISO 14644
    4. Sterile and non‑sterile manufacturing facilities

  • Hands‑on experience in:

    1. Re‑qualification and periodic review programs
    2. FAT and SAT execution and documentation

  • Strong experience in:

    1. Process validation, cleaning validation, sterilization validation, and aseptic process simulation (media fills)
    2. Gowning qualification, visual inspection qualification, and transport validation

  • Practical knowledge of calibration systems, including rationale, acceptance criteria, frequency setting, and outsourced calibration management

  • Solid experience in Computerized System Validation (CSV):

  • Validation of manufacturing, utilities, QC, and validation systems

  • Compliance with 21 CFR Part 11 and data integrity (ALCOA+) principles

  • Strong experience in EQMS activities, including:

  • Change Control impact assessments

  • Deviation investigations and root cause analysis

  • CAPA development and effectiveness checks

  • Audit support and regulatory inspection readiness

  • Experience acting as validation SME during internal, customer, and regulatory audits, including SFDA inspections

  • Strong leadership and team‑coordination skills with experience assigning and reviewing work of validation engineers and SMEs

  • Excellent analytical, problem‑solving, and risk‑assessment skills

  • Proficiency in MS Office and electronic QMS / validation management system

 

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