Document Reviewer

4 weeks ago


Durban, KwaZulu-Natal, South Africa Jobking Full time
Job Description

  • Ensure compliance with statutory requirements and requirements of Good Manufacturing Practice and cGMP in all activities and specifically in the generation of and review/audit of BMR/BPR's.
  • Compliance to the SA OHS (Act) /Health, Safety and Environment policy of the organization.
  • Generation of new BMR/BPR and related protocols/documents, as well as update of BMR/BPR and related documents via the Change Control Process
  • Monitoring of shop-floor (Manufacturing/Packing/Stores/QC) activities and review of related documents/ on-line BMR/BPR auditing
  • Auditing of batch records in accordance with Company SOP to ensure data integrity, compliance with cGMP and Regulatory requirements.
  • Follow up on BMR/BPR query and close out with relevant level
  • Review/ auditing of production shop-floor activities to ensure compliance to cGMP and regulatory requirements.
  • Administrative activities to support release plan such as H1 update, Syspro tasks,
  • To review the following documents and ensure compliance to prepare for QA Final Batch Release
a. In-process data
b. Bulk reconciliation data
c. Product yield data
d. Manufacturing and Packaging Job Record check lists
e. Job Clearance information
f. Non-conformance records
g. Syspro printouts

  • Receiving and logging of documents for auditing
  • Control and Tracking of documentation
  • Conduct BMR/BPR auditing to a Not Less Than 95% Right First-Time level, prior to QA Log-in
  • Preparation of Protocols and maintenance of log books
  • Requisition and collation of additional release documents as and when required
  • Co-ordinate the Production Sample log-in to QC Laboratory
  • Trending of BMR/BPR errors and planning of relevant Corrective and Preventative actions to prevent repeat errors
  • Training on relevant SOP's and Documents
  • Follow instructions/activities as delegated
Requirements, Qualifications & Experience
Matriculation with a pass in Mathematics and English
Basic/Post Basic Pharmacist Assistant (advantageous)

Minimum 3 years experience in a Pharmaceutical manufacturing environment
Experience in Document Auditing of BMR/BPR
GMP knowledge and experience
Computer Literacy and skills

Duties & Responsibilities
Refer to job description

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