Job Description
This position exists as a QA function in Microbiology with its primary purpose to ensure all microbiological testing, associated investigations and reports are completed on time. This role will support routine operation of the Microbiology Lab, oversees monitoring of environment systems (HVAC/cleanroom, compress gases, water), perform risk assessments, biocompatibility testing of materials.
Duties and Responsibilities
• Working knowledge in cGMP and other regulations in order to assure laboratory compliance.
• Report Observations.
• Revise SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines.
• Send Laboratory equipment out for calibration.
• Review/approve equipment.
• Initiate and resolves quality investigations for excursions relating to routine laboratory testing and equipment calibrations.
• Supports Change Controls and CAPAs.
• Perform routine testing, documents and reports results while following validated procedures for raw materials, in process samples, utilities / environmental monitoring and validation testing under the assigned direction of the supervisor or designee.
• Complete verification for environmental monitoring, in-process samples and utilities
• Assist with the execution of validation protocols and reports.
• Supports regulatory audits as needed.
Qualifications and Experience
• Bsc. Degree in Biology, Microbiology or other related science field. A Minimum of 3 years of experience in a Microbiology Lab and Medical device industry experience
• knowledge of cGMPs, GLP, and regulatory guidelines for control environments and sterilization of medical devices.
• Experience with Microsoft suite as well as good communication skills.
• Ability to follow laboratory testing procedures.
• Experience in monitoring of environmental systems (HVAC, Cleanroom, Compressed Air, Compressed Gases, Water)
How to Apply
Suitable and interested candidates to forward applications and CVs to pharmaceuticalrecruitments@gmail.com indicating the position in the subject line. Due date for submission of applications is 18/06/21 COB
