Document Reviewer

Job Description
1. 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.
2. Compliance to the SA OHS (Act) /Health, Safety and Environment policy of the organization.
3. Generation of new BMR/BPR and related protocols/documents, as well as update of BMR/BPR and related documents via the Change Control Process
4. Monitoring of shop-floor (Manufacturing/Packing/Stores/QC) activities and review of related documents/ on-line BMR/BPR auditing
5. Auditing of batch records in accordance with Company SOP to ensure data integrity, compliance with cGMP and Regulatory requirements.
6. Follow up on BMR/BPR query and close out with relevant level
7. Review/ auditing of production shop-floor activities to ensure compliance to cGMP and regulatory requirements.
8. Administrative activities to support release plan such as H1 update, Syspro tasks,
9. 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
10. Receiving and logging of documents for auditing
11. Control and Tracking of documentation
12. Conduct BMR/BPR auditing to a Not Less Than 95% Right First-Time level, prior to QA Log-in
13. Preparation of Protocols and maintenance of log books
14. Requisition and collation of additional release documents as and when required
15. Co-ordinate the Production Sample log-in to QC Laboratory
16. Trending of BMR/BPR errors and planning of relevant Corrective and Preventative actions to prevent repeat errors
17. Training on relevant SOP’s and Documents
18. 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

Apply Here http://bit.ly/2turVxx

Job id : , #69476, 239 views,

« SS: SSC Administrator: Records and ControlsQuotations Analyst Assistant »