Plus Five Pharmaceuticals

Quality Control Analyst

Applied Sciences, Aviation Jobs
Salary
Negotiable

Job Description

Position Objectives
1. Adherence to Good Laboratory Practices and the current Good Manufacturing Practices
2. Ensuring strict compliance to the current Good Manufacturing Practices
3. Sampling of all starting materials within two days of receipt
4. Carrying out all in-process checks to control product quality and finished product analysis.
5. Analysis of finished products within one day of production.

Duties and Responsibilities

1 Full analysis of all pharmaceutical and non-pharmaceutical raw materials within two days of receipt according to the BP, USP and other Pharmacopoeia and QC specifications.
2 Analysis of water samples daily and prior to manufacturing, and report compilation
3 Analysis of all packaging material (labels, leaflets, containers, closures and cartons) within two days of receipt and compile full reports
4 Taking water samples for analysis for as long as the water plant is running
5 Ensuring that all raw materials are placed in the Raw Materials Quarantine and are affixed with Quarantine stickers
6 Affixing status stickers on passed/rejected raw materials
7 Documentation of all analytical reports, test results, running files and raw materials files
8 Analysis of intermediate and bulk products
9 Analysis of finished products within one day of their production
10 Analysis of stability samples as per stability programme and reports compilation
11 Analysis of process validation samples
12 Analysis of clean down validation samples
13 Carrying out Analytical Method Validations for all analytical methods
14 Processing of customer complaints within three days of receiving them as per instruction from the QC Manager
15 Ensuring that all work done is documented
16 Ensuring that all starting materials received are logged into the running file
17 Inspection of production and stores area for risk of cross contamination, mix-ups.
18 Ensuring that all retention samples are logged into the retention samples’ logbooks
19 Performing daily calibrations on the pH meters, Analytical balances and moisture analyzer
20 Calibration of secondary standards from primary standards
21 Ensuring that all materials (raw materials and packaging) bear relevant status stickers at any time and that they are stored appropriately.
22 Informing Stores personnel on released starting materials
23 Informing the team leaders and production supervisors in production in process results
24 Adherence to lab safety standards and all QC related SOPs
25 Supervision of all laboratory technicians and taking inventory of laboratory requirements
26 Performing daily calibrations and verification of lab equipment as per relevant SOPs
27 Checking of emergency body and eyewash station as per SOP
28 Ensuring that the laboratory is kept clean and log sheets are up to date
39 Informing the QC Manager on any analysis problems and out of specification results.
30 Issuing of analytical and production worksheets

Qualifications and Experience

This position requires the job holder to possess the following minimum qualities:
• BSC BioChemistry / Chemical Technology/ Applied Chemistry
• Good knowledge of the current Good Manufacturing Practices and Good Laboratory Practices
• Firm and Assertiveness
• Reliability and Innovativeness
• Teamwork and organizational skills
• Ability to work under pressure
• Good written and spoken English
This is a full-time position based in Bulawayo and assumes that the job holder will fulfill the necessary working hours.

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