Job Description
Key Roles and Responsibilities:
* Provide QA input to project activities, including review and approval of change requests, specifications, Standard Operating Procedures, Manufacturing Procedures, and Analytical Procedures.
* Participate in quality-related investigations and assist in the development and approval of effective CAPA to resolve production, audit, and customer issues.
* Identify and escalate any cGMP areas of concern.
* Participate in validation activities, including approval of protocols and reports for analytical methods, manufacturing processes, analytical/production/packaging equipment, and cleaning procedures.
* Participate in audits of suppliers, production, and support functions as required.
* Assist in preparations for MHRA/FDA and other regulatory body audits.
* Review documentation related to incoming raw materials and perform disposition activities as required.
* Review manufacturing, laboratory, and related documentation prior to final product disposition, highlighting potential issues to the QA manager.
* Act as the QA representative for new product introductions, collaborating with R&D, QC, and manufacturing to ensure all cGMP documents and requirements are met.
Competencies:
* Attention to detail
* Effective verbal and written communication skills
* Good organizational skills
* Ability to work independently and as part of a team
* Data analysis and decision-making skills
* Root cause analysis and problem-solving abilities
* Workload prioritization to meet deadlines
* Accurate following of instructions
* Appropriate issue escalation
Qualifications
Essential Qualifications:
* BSc in a relevant scientific discipline or equivalent
Essential Experience:
* Minimum of 3 years’ experience in a cGMP manufacturing environment for Active Pharmaceutical Ingredients
* College/University qualification in a scientific subject
* Experience with quality assurance, analytical chemistry, development, and manufacturing groups is beneficial
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