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cGMP Compliance Auditor

  • Job type: Permanent
  • Location: Memphis, Tennessee
  • Salary: US$80000 - US$100000 per annum
  • Job reference: 174011/001_1528817948
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 12/06/2018

POSITION SUMMARY:

Reports directly through this organization's Legal & Compliance function. You will be responsible for conducting independent internal cGMP and Data Integrity audits to ensure that this organizations 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 organization and regulatory requirements.
* Perform internal audits including those covering data integrity and OOS investigations.
* Execute the audit per organization 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 our organization 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.

  • Healthcare for associates and eligible dependants, same-sex and domestic partners

  • Paid time off, including vacations and holidays

  • Paid volunteer time off

  • Life insurance and disability protection

  • Pet insurance

  • Employee Stock Purchase Program

  • Retirement benefits and more…

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.

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