Quality Analyst

The Batch Record Release Coordinator is a critical role within our Quality Assurance department, responsible for the thorough review and approval of executed batch records from our external business partners to ensure compliance with internal standard operating procedures (SOPs), Good Manufacturing Practices (GMP), and regulatory requirements. The ideal candidate will possess a strong understanding of Good Documentation Practices (GDP) and demonstrate exceptional attention to detail. This role requires the ability to manage multiple priorities and meet strict deadlines in a fast-paced environment.

Key Responsibilities:

1. Batch Record Review:

• Conduct comprehensive reviews of batch records for accuracy, completeness, and compliance with GMP and GDP standards.
• Ensure all required documentation is present, including but not limited to, production records, equipment cleaning and sanitization logs, and quality control results.
• Identify and escalate any discrepancies or deviations in batch records, facilitating timely resolutions.

1. Documentation Practices:

• Uphold and promote Good Documentation Practices throughout the organization.
• Identify Good Documentation Practices improvement areas via batch record review and communicate these to the External Business Partners as appropriate.

1. Collaboration and Communication:

• Work closely with cross-functional teams, including Production, Quality Control, and Regulatory Affairs, to facilitate efficient batch record review processes.
• Communicate effectively with team members and management regarding batch record issues, trends, and compliance challenges.

1. Prioritization and Time Management:

• Manage and prioritize multiple batch record reviews simultaneously, ensuring timely release of products in accordance with production schedules across multiple Contract Manufacturing sites and product forms (cosmetics, medical devices, and drugs).
• Adapt to changing priorities and deadlines while maintaining a high level of accuracy and thoroughness in reviews.

P&G's freelancer opportunities are for project-based or other short-term engagements that require specialized skills. Successful candidates for freelancer opportunities will not be considered employees of The Procter & Gamble Company or any of its subsidiaries nor will candidates be eligible for employment benefits. Candidates looking for regular full-time employment opportunities should begin their search here: pgcareers.com.

• Published on 16 Jan 2025, 2:55 PM