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Document Control Pharmacist

Purpose:

  • To ensure that released starting materials, trial materials and bulk and finished oral solid dosage (OSD) products (as well as all associated documentation) comply with GMP guidelines, regulatory and in-house requirements
  • Exercise pharmaceutical responsibility for product release for use into the marketplace
  • To ensure new launch requirements are met

Key Responsibilities:

  • Translates priorities list from Production Planning into work schedule to ensure that market demands are met
  • Compile and maintain departmental operating procedures and standard forms
  • Maintain Bill of Materials, Item Master and Lot Masters in BAAN
  • Develop master batch records (BMI’s, BMR’s, BPR’s) in compliance with the dossier and GMP requirements
  • Train relevant personnel on batch documentation
  • Recommend and implement improvements to documentation
  • Approve and unblock raw materials and components (In conjunction with the laboratories)
  • GMP audit of all bulk and finished product documentation and final release approval for sale
  • Control of disposition batch records, retention samples and lot documents
  • Assist with departmental training

Job requirements: 

  • Qualified Pharmacist registered with the SA Pharmacy Council.
  • At least 1 year experience in the Pharmaceutical Industry, preferably in OSD Manufacturing Facility.
  • Clear understanding of Pharmaceutical requirements and a good working knowledge of GMP.
  • Computer literate – Word, Excel, QUMAS, Process Compliance
  • Baan knowledge is advantageous

Reference Number: 

DocPharm730

Company: 

Aspen

City: 

Port Elizabeth

Country: 

ZA

Salary: 

Market Related

Job Type: 

fulltime

Industry: 

Pharmaceutical And Medical/Healthcare