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Operational Quality Officer

 Operational Quality Officer

Operational Quality Officer
Operational Quality Officer

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

Contact Information

You may apply for this position online by selecting the Apply now button.

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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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