QA Release

Main Responsibilities

Quality Review of Batch Records

• Perform final Quality review of completed manufacturing records for completeness and accuracy according to site procedures, cGMP, FDA's 21 CFR, and other applicable health authority regulations.
• Complete all required system transactions associated with the batch record review process.
• Provide data for PDR manufacturing dates and Commodity Verification Sheets to allow further processing of material.

Disposition of Batches

• Review Specification Checklist, Certificate of Analysis (and Conformance) to verify all required testing has been performed and all testing meets requirements prior to batch disposition.
• Verify CBER release is received (if applicable) prior to batch disposition.
• Verify the lot is not on hold (i.e., deviations, change controls, Approve for Further Manufacture database, etc.) prior to batch disposition.
• Verify all previous manufacturing steps, including raw materials, are satisfactory prior to final disposition of the batch.
• Complete all required system transactions associated with the batch disposition process.
• Act as delegate to the QA Release Lead to provide approval to ship to external manufacturers, as assigned.

Quality Preparation and Review of Lot Release Protocol (LRP)

• Prepare and Review working LRP for completeness and accuracy prior to submission to the applicable Health Authority.
• For licensed international products, ensure the batch is in full compliance with the GMP requirements and the specifications in the Marketing Authorization of the importing country.
• Ensure LRP review meets cycle time requirements for product releases and SAP confirmation for completion of activity.

Preparation of Environmental Monitoring Summary (ESUM)

• Oversee the ESUM process to ensure timelines and compliance standards are met.
• Take assigned lots and complete ESUM reports by compiling and reviewing data in compliance with area EM procedures, finalizing ESUMs in the electronic ESUM database, and meeting release timelines.
• Serve as the SME and function as a liaison for any assigned focus factory initiatives and participate on teams, communicating issues and identifying solutions to support release timelines.
• Contribute to team objectives and priorities on assigned projects.

Preparation & Certification of Working Documents

• Prepare batch records from master documents in the electronic document management system according to procedure.
• Ensure right first time preparation and completion of required documentation via electronic system (SAP and/or FaCT).
• Provide support as required to ensure records are prepared and certified in accordance to the production planning schedule.
• Certify prepared batch records to ensure completeness and accuracy in accordance to procedure.
• Provide metrics in support of +QDCI board meetings.

Compliance and Performance

• Meet department safety, quality, productivity, and cost targets and goals in a compliant and timely manner.
• Act as Trainer for Batch Release activities.
• Investigate deviations, as assigned.
• Perform special projects as assigned by FFIP QA Leadership team.
• Continuously review PQBR processes, and recommend, develop and implement efficiency and quality enhancements.
• Perform CAPA review and approval as required.
• Complete additional tasks as assigned by team Lead.

Key Involvement in Decision Making

• Prioritize quality and compliance objectives (D).
• Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D).
• Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D).
• Review documentation for batch disposition (A).
• Advise on initiatives to promote a quality-focused culture (A).
• Advise on how to present a topic and answer specific questions (A).

About You

Basic Qualifications

• Bachelor's degree.
• 1+ years of experience in a GMP-controlled pharmaceutical environment (e.g., Quality Assurance, Production, Quality Control or related areas).

Technical Skills

• Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards.
• Capability to investigate and resolve issues or deviations related to batch release processes efficiently.
• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards.
• Strong computer literacy (including Microsoft Excel, PowerPoint, Word).

Soft Skills

• Ability to analyze complex data and identify trends, issues, and solutions.
• High level of accuracy and attention to detail in all quality assurance activities.
• Proficiency in identifying problems and implementing effective corrective actions.
• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies.
• High level of autonomy.