Medical Device Quality System jobs

The QA Batch Release Officer is responsible for reviewing and approving all documentation relating to products manufactured at ADM Protexin, ensuring compliance with applicable quality standards such as pharmaceutical GMP,
food and feed safety. The role involves batch documentation review, shop floor quality oversight, line audits, internal audits, and the management of deviations and non-conformances to ensure product quality, patient safety, and regulatory compliance.

Main Responsibilities:

Batch Review and Release

• Perform detailed review of batch manufacturing and packaging records to ensure completeness, accuracy, and compliance with approved procedures, GMP, and food and feed safety standards.
• Verify that all non-conformances and out of specifications are appropriately documented and resolved prior to batch disposition.
• Review and approve testing documentation and Certificates of Analysis (CofA), and disposition batches.

Line Audits and Shop Floor QA Support

• Conduct routine line audits and inspections to verify compliance with approved manufacturing and packaging procedures.
• Identify and escalate quality or compliance concerns and work with operations teams to ensure prompt resolution.
• Provide QA support and guidance to production teams during manufacturing activities.

Internal Audit Support

• Participate in internal audits to assess compliance with GMP and food and feed safety standards.
• Assist with audit preparation, documentation review, and follow-up activities.
• Support implementation of corrective and preventive actions resulting from audit findings.

Product Quality Reviews (PQRs)

• Collect and collate data, and write reports for PQRs, ensure ongoing product quality, process consistency, and regulatory compliance.
• Review and analyse quality data, deviations, complaints, trends, and batch performance to identify improvement opportunities.
• Collaborate with cross-functional teams to support actions arising from product quality review activities.

Non-Conformance and Deviation Management

• Support investigation of deviations, non-conformances, and quality incidents using root cause analysis tools.
• Assist in the implementation and tracking of corrective and preventive actions (CAPAs).

Documentation and Quality Systems

• Ensure accurate completion and maintenance of QA documentation, logs, and records.
• Support updates and improvements to SOPs, quality systems, and compliance procedures.
• Maintain effective communication with cross-functional departments regarding quality matters.

Continuous Improvement

• Identify opportunities to improve QA processes, compliance performance, and operational efficiency.
• Participate in continuous improvement projects and quality initiatives.

Skills & Abilities:

• Strong attention to detail and observational skills.
• Good communication and interpersonal abilities.
• Ability to work effectively in a fast-paced manufacturing environment.
• Strong organizational and problem-solving skills.
• Ability to work independently and as part of a cross-functional team.

Education & Experience:

• Degree (or equivalent) in a STEM related subject is preferable but not essential
• At least 2 years’ experience in a quality role within a Pharmaceutical or Food Manufacturing environment

#IncludingYou

Diversity, equity, inclusion and belonging are cornerstones of ADM’s efforts to continue innovating, driving growth, and delivering outstanding performance. We are committed to attracting and retaining a diverse workforce and create welcoming, truly inclusive work environments — environments that enable every ADM colleague to feel comfortable on the job, make meaningful contributions to our success, and grow their career. We respect and value the unique backgrounds and experiences that each person can bring to ADM because we know that diversity of perspectives makes us better, together.

About ADM

At ADM, we unlock the power of nature to provide access to nutrition worldwide. With industry-advancing innovations, a complete portfolio of ingredients and solutions to meet any taste, and a commitment to sustainability, we give customers an edge in solving the nutritional challenges of today and tomorrow. We’re a global leader in human and animal nutrition and the world’s premier agricultural origination and processing company. Our breadth, depth, insights, facilities and logistical expertise give us unparalleled capabilities to meet needs for food, beverages, health and wellness, and more. From the seed of the idea to the outcome of the solution, we enrich the quality of life the world over. Learn more at www.adm.com.

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