AC11575 Chemistry Document Reviewer – Fixed Term Contract

at Alec Cameron & Associates Recruitment Solutions
Location Alberton, South Africa
Date Posted September 5, 2022
Category Education / Teaching
Job Type Full-time
Currency ZAR

Description

Our Client is looking for a Chemistry Document Reviewer on a Fixed term contract basis. The right Candidate would need to have a BSc or ND in Chemistry, 2 to 3 years experience in a lab in the Pharmaceutical industry, knowledge of SOP's, knowledge og GMP and knowledge of analytical instrumentation and data review.

Duties & Responsibilities

  • Reviewing of data documented by laboratory personnel within laboratory notebooks, worksheets and instrument logbooks.
  • Reviewing of documentation related to in-process, finished product, raw materials and stability testing in the laboratory
  • Reviewing of audit trail to ensure that the electronic data generated is according to the applicable procedures.
  • Performs review of analytical data and calculations associated with material testing, and analytical methods
  • To priorities reviewing of analytical data to strict timescales and as per the emergency of release.
  • Performs evaluation of Out of Specification with the laboratory analyst.
  • Informs manager or designate of any critical data integrity or issue of irregularity.
  • Review reagents, standards and standardized Solution in the “P” Book.
  • Review the working and reference working Standards and verify that the correct grade and Potency has been used.
  • Reviews that the Samples were taken from the correct sampling points and that testing was performed testing as per 03-15-23-004.
  • Ensuring the Lab equipment in handled with care and non-abuse.
  • Switching off the equipment when not in use.
  • Ensuring cleanliness of the laboratory
  • Follow Safety and GMP requirements as instructed
  • Complying with Standard Operating Procedures (SOP’s)

 

Core Competencies

  • Judgement and Decision Making
  • Verbal and written communication skills
  • Customer Service Orientation
  • Quality Orientation
  • Assertiveness
  • Rule orientation
  • Flexibility
  • Attention to detail
  • Stress Handling

Desired Experience & Qualification

  • BSc Degree or National Diploma in Chemistry
  • 2 – 3 years Lab experience in Pharmaceutical Industry
  • Knowledge of laboratory SOP’s
  • Knowledge of pharmaceutical GMP
  • Knowledge of using analytical instrumentation and data review
  • Strong analytical and problem solving
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