Quality Control Analyst

Overview

QC Analyst providing analytical expertise, managing standards, ensuring GMP compliance

Key Responsibilities

• audit support
• cgmp compliance
• analytical expertise
• troubleshooting
• qualification
• standards management

Tasks

-Providing audit support to the QC team including performing routine and pre-audit walkthroughs, assisting SMEs to prepare and coordination of QC requests during audits -Ensure compliance to cGMP at all times -Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means. -The function of this position is to provide his/her analytical expertise for any project, troubleshooting, investigation on analytical methods and lab technologies. -Seeing tasks through to successful completion -Support with inter-site qualification and extension of controls and standards. -Management of standards, controls and critical reagents in the QC laboratory -Reviewing and updating QC procedures and processes to ensure compliance to current and updated requirements and regulations e.g. new or updated pharmacopoeia chapters -Preparation of qualification memo's in Veeva to support QC testing activities.

Requirements

• science degree
• pharma qc
• gmp
• analytical
• 3+ years
• detail oriented

What You Bring

-Ability to interact effectively in multi-disciplinary teams -Higher Level degree in science or equivalent technical discipline -Excellent communicator and attention to detail -Ability to drive project deliverables/goals to closure -Willingness to take ownership for resolution of departmental and/or cross functional issues -Proficiency in identifying issues and implementing effective solutions to resolve quality control problems. -3years + experience within Pharmaceutical Development, Analytical and/or Manufacturing department -Ability to analyse complex data and laboratory results to make informed decisions and identify areas for improvement. -Brings scientific rigour and discipline to approaches -Flexible approach, comfortable with ongoing change and improvement in the organisation -Experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements. -Ability to work autonomously while maintaining communication with key stakeholders -Ability to articulate issues and communicate at all levels, in particular with departmental management and program leads -Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements.

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