Skills

  • Teamwork
    10
  • QA Executive
    10
  • Validation officer
    10
  • Process validation
  • Cleaning Validation
    10
  • English
    10

Experience

lenny

Work experience
  • 1. GMP (Good Manufacturing Practices) administration within the facility.
  • 2. In charge of IPQA (In Process Quality Assurance) officers and reviewing of In Process reports.
  • 3. In Charge of Protocol Preparation and execution for Cleaning Validation, Equipment Qualification and Process Validation.
  • 4. Determination of Hold Time Studies for different Raw Materials and Intermediates.
  • 5. Preparation and review of Standard Operating Procedures (SOPs).
  • 6. Handling of QMS (Quality Management Systems) documents such as market complaints, Change Controls, Deviations, Product recalls and Reprocessing/Reworking.
  • 7. Conducting self-inspections and CAPA follow up (Corrective Action and Preventive Action)
  • 8. Review of Executed Batch Records, COAs, FPPs before batch release.

lenny

Work experience
  • February, 2020 - December, 2021
  • Fulltime
  • Conducting Cleaning Validation, Process Validation and Equipment Qualification and
  • Ensuring GMP (Good Manufacturing Practices) adherence in Production area.
  • 1. Preparation and review of Standard Operating Procedures (SOPs).
  • 2. Handling of QMS (Quality Management Systems) documents such as market complaints, change controls deviations, product recalls and reprocessing/reworking.
  • 3. Review of Executed Batch Records.
  • 4. Conducting self-inspections and CAPA follow up (Corrective Action and Preventive Action)

Related persons

nancy zainBUSINESS ADMNISTRATION