Reports directly through PharMEDium’s Legal & Compliance function. You will be responsible for conducting independent internal cGMP and Data Integrity audits to ensure that PharMEDium operations remain compliant with governing standard operating procedures, regulatory requirements, regulatory commitments and, most importantly, FDA’s cGMPs requirements for 503B Outsourcing Facilities.
PRIMARY DUTIES AND RESPONSIBILITIES:
• For the assigned facility, support and implement the Compliance function’s Audit Processes and procedures in accordance with applicable PharMEDium and regulatory requirements.
• Perform internal audits including those covering data integrity and OOS investigations.
• Execute the audit per PharMEDium procedures from planning to closure which includes; issuance of agenda, performance of audit, drafting and issuance of reports, evaluation of investigations and associated corrective actions, verification and tracking of corrective actions and their effectiveness.
• Interview personnel, review production and laboratory data, documents, records and procedures and identify non-compliant conditions or practices.
• Escalate objectionable cGMP practices to Legal & Compliance management
• Prepare and communicate a weekly summary of the compliance state of the facility operations, identification of any non-compliance conditions, adequacy of investigations performed by the facility and any additional training needed for facility personnel.
• Perform any needed follow-up activities including investigations and audits on an as-needed basis
• Provide identified quality metric data for Compliance Program Review meetings (monthly, quarterly)
What your background should look like
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
• BS/Advanced degree in Chemistry or in Microbiology with
• 5-8 years of external regulatory audit, compliance remediation and internal GMP audit experience
• 5+ years’ of specific pharmaceutical GMP experience required
• 3+ years demonstrated expertise in laboratory and manufacturing investigations
• Familiarity with aseptic processing environmental monitoring and cleaning, strongly preferred.
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
Working knowledge and understanding of 21 CFR 210, 211 cGMP regulations, U.S. Pharmacopeia as well as salient FDA Guidance for Industry
• Knowledge of Part 11 and data integrity compliance
• Ability to use scientific principles/process/regulatory knowledge to identify critical compliance issues
• Interact and communicate with Sr. Management effectively
• Effective verbal and written communication skills
• Ability to provide guidance and resolve conflicts
What AmerisourceBergen offers
We offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.
Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.
AmerisourceBergen is a publicly traded Fortune 11 global healthcare solutions company and is one of the world's largest pharmaceutical services companies. Powered by our associates around the world, we provide pharmaceutical products and business solutions that improve access to care. We operate the backbone of the healthcare supply chain. We drive the future of local care delivery. We guide medical innovations to market. We create healthier futures.