Job Purpose:

The purpose of the Batch Record Review (BRR) role is to ensure that all manufacturing and packaging processes comply with regulatory standards, company policies, and quality requirements before product release. This role plays a critical part in maintaining product integrity, patient safety, and regulatory compliance by verifying that production records are complete, accurate, and meet Current Good Manufacturing Practices (cGMP) and other industry regulations (e.g., FDA, ISO).

By meticulously reviewing batch documentation, identifying deviations, and ensuring corrective actions are taken, the BRR role helps prevent product defects, recalls, and compliance issues, ultimately safeguarding public health and maintaining company credibility.

Essential Duties and Responsibilities:

• Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate.
• Performs final batch disposition of finished drug product and combination product batches, to ensure high quality medicine (cGMP Compliance) is released within expected metrics to ensure timely release to market.
• Performs review checklist to verify all requirements have been performed and meet requirements.
• Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices (GDP).
• Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices, including but not limited to executed batch records, master batch records, and product specific documents.
• Independently executes batch record review for completeness, accuracy and cGMP compliance.
• Support the evaluation and lot disposition of drug product. Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and Standard Operating Procedures (SOPs).
• Contributes to process improvement of batch records and associated processes (e.g. turnaround times) to ensure all Quality Assurance (QA) batch disposition deadlines are met.
• Responsible for the review and approval of cGMP documentation against SOPs in order to ensure compliance in Manufacturing processes.
• Raise deviations as needed in order to capture potential impacts to product quality.
• Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management.
• Work with colleagues to instill a sense of ownership and commitment to quality.
• Provide technical support to the leadership team in the decision-making process.

Supplemental Functions:

· Performs and maintains archiving of all batch documentation to include copying, scanning, and filing.

• Revise or review standard operating procedures and submit procedural changes as needed to meet local, Global and Regulatory requirements.
• Keep abreast of industry developments, forthcoming regulations, guidance, best practices, etc for all Scientific Areas.
• Performs and assists with additional work duties or responsibilities as assigned or apparent.

Job Specifications and Qualifications:

Knowledge & Skills:

• Comprehensive knowledge of quality system requirements such as US FDA, cGMP, GCP, EMA, and ICH guidelines and has a proven track record of successfully implementing these requirements to ensure patient safety and compliance with FDA and other applicable health authorities’ requirements.
• Competent in Microsoft Word and Excel.
• Knowledgeable in Adobe Acrobat (PDF) advanced features and workflows.
• Familiar with document management software, including SharePoint.
• Excellent written and oral communication skills.
• Team player and must be able to interact with all departments.
• Ability to work independently and be dependable.
• Technical writing skills required.
• Strong attention to detail.
• Specific expertise, skills, and knowledge within Quality Assurance gained through education and experience.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to manage a multitude of resources and to be accurate and current with data and information.

Education/Experience:

• BS degree preferred with at least 1 year of experience in a regulated cGMP Environment. In lieu of degree, at least 4 years of equivalent experience in pharma manufacturing operations considered and strong background in GDP.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), vision (20/20). Standing (10%), sitting (80%) and walking (10%) throughout the facility.