AC11575 Chemistry Document Reviewer – Fixed Term Contract
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