Operational Quality Officer At GSK-pharmacy Vacancies-Quality jobs
Department: Quality
Job description
Site Name: Egypt - Cairo
Posted Date: Feb 17 2021
Job Purpose
Follow up adherence to OQ system and GMP in production areas, check batch-related documentation, and handling of all MOH requirement.
Key Responsibilities:
Handle all MOH requirements for all received raw materials, finished products release including NODCAR sealing and follow up.
Handle MOH inspector visits within Cairo site and any central administration of pharmaceutical affairs required visits (CAPA).
Responsible for Archiving of all MOH documents within Cairo site.
Revise Quality technical documents according to Corporate Standards, such as GQP’s, GQG’s, GQMP’s and FPG’s. This includes batch manufacturing and packaging documents, specifications, SOPs and bills of materials.
Ensure proper sampling of intermediate, bulk and finished product batches for routine testing, validation practices and cleaning samples.
Follow up application of OQ measures in production areas and check compliance of in process testing.
Monitor calibration of production equipment and IPC testing instruments.
Review batch related documentation for completeness, correctness and compliance to approved standards.
Ensure that GMP Standards are followed properly in the Warehouse, Dispensing and manufacturing areas and during the manufacturing processes.
Handle deviation, complaints and OOS in coordination with area owners and ensure implementation of CAPA and closure within required timeline.
Knowledge/ Education / Previous Experience Required:
University Bachelor’s degree in Pharmacy.
Minimum 2 years of diversified experience in Quality Assurance or Regulatory department.
Good understanding of regulatory guidelines
Good knowledge of GMP requirements
Excellent communication and interpersonal skills
Actively seek to improve processes, controls and expand effectiveness and efficiency.
Self-motivated with Good prioritization and organization skills
Ability to work independently and as part of a team
Flexibility to work Night shifts as part of a shift rotation with other team members.
Good command of the English language
Good Computer Skills