QC analyst

QC Analyst for testing of pharmaceutical drug substances and reference standards in accordance with corporate procedures and in compliance with the current GMP standards.

Job Description

Key Responsibilities

• Carry out testing of drug substances in accordance to the valid testing procedures and regulatory requirements
• Ensure that laboratory equipment are well maintained, and calibrations are carried out at the designated frequencies.
• Review results generated by other analysts for compliance with requirements.
• Ensure that all target dates are met. Communicate status of testing at Tier 1 Unit meetings.
• Maintain laboratories to a high housekeeping standard.
• Carry out method transfers and participate in the validation of analytical test methods as required.
• Write and maintain necessary documentation (test protocols, SOPs, instrumentation manuals and checkout sheets, method transfer reports,) according to the existing SOPs and cGMP standards.
• Lead Laboratory investigations and deviations if required.
• Assessment of testing results generated in the laboratory and close out of batch analysis.
• Maintain a safe working environment, in a state of audit readiness.
• Maintain own state of the art knowledge of cGMPs and relevant analytical techniques.
• Identification and implementation of safety, environmental, quality and service improvements
• Work with their leader to ensure self-development and progression

Qualifications

• Science Graduate in Chemistry or equivalent education with greater than 3+  years’ experience.
• Experience with current Good Manufacturing Practices (GMP) and sound knowledge of analytical technologies with demonstrated troubleshooting skills.
• Previous hands-on experience in a regulated laboratory within the pharmaceutical industry would be an advantage (HPLC, GC, UV, PSD, XRPD, wet chemistry, dissolution, etc.).

Additional information 

• Integrity, consistency and flexibility
• Professionalism; how you conduct yourself with the client, contractors and colleagues at all times
• Strong analytical ability and associated problem solving
• Organisational skills and computer literate
• Good time management & attention to detail
• Results and performance driven
• Compliance with SGS policies and procedures
• Participate in team meetings / Team player/ Self directed
• Excellent communication skills both verbal & written