QA Officer

2 weeks ago


Riyadh, Ar Riyāḑ, Saudi Arabia MS Pharma Injectable Full time

Company: MS Pharma – KSA Industry: Pharmaceuticals Job Location: Riyadh, Saudi Arabia Career Level: Junior (With some experience in the field) Date Posted: Ref. Number: Citizenships Saudi Arabia Residence Country Saudi Arabia

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Establish, maintain and update QMS policies and procedures to ensure that products and processes meet applicable standards and specifications, provide technical expertise during internal and external audits and manage related corrective and preventive actions.

Main Responsibilities:

  • Follow up production process to ensure the quality of products by checking performing test during processing & packaging which includes the following SOP 's: -

A – Powder.

B – Tablets.

C - Syrups, Shampoo, Dry suspension, Solutions.

D – Creams & ointment.

E - Hard & Soft Gelatin capsules.

F – Suppositories.

G - Sampling: Sampling of bulk, powders and finished products.

H – Blistering.

J- Printing.

  • Checking the products from each stage according to the Acceptable quality limit SOP, and to give approval for the transition to the next stage.
  • Ensure the definition of rooms, materials and all products in the production areas.
  • Daily and periodic tours to ensure GMP rules are applied in production.
  • Ensure the application of good documentation rules.
  • Ensure that the equipment and balances are used in the IPC department within the calibration time.
  • GMP Compliance:
  • Ensure GMP Compliance for daily activities during batch manufacturing (housekeeping, Line clearance, Deviations encountered, calibration, Preventive maintenance, yields, reconciliation ...ETC)
  • To ensure the warehouse complies with good storage practice and material handling during daily rounds.
  • Initiate GMP deviation report when GMP Non- compliance observed and follow up corrective actions.
  • carry out investigation for production failure and/or out of specification (OOS).
  • Follow up with failure Reports and put down appropriate corrective and preventive actions.
  • Batch record review prior release:
  • Review each batch record & initiate investigation for observations found in batch records.
  • follow-up action taken and close the investigation.
  • Review and approve MF, PF, MI, PI, perform failure investigations, follow-up CAPAs, GMP compliance tours, prepare for audits, assess deviations and change controls.

Requirements:

  • B.Sc. or Diploma Degree in pharmacy, chemistry or in any scientific field
  • 0-2 years' experience in related field.
  • Proficiency in written, read and spoken Arabic and English Languages
  • Knowledge in the systems such as ICH, GMP, GLP, WHO
  • Knowledge in Quality Requirements (local, regional, global requirements)
  • Troubleshooting & failure investigation.
  • Applicable GMP guidelines including EMA, WHO and JFDA guidance's
  • Manufacturing processes stages and techniques at MSPS
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