Assure compliance with federal regulations and company standards for all computerized systems and equipment for Purdue Pharma L.P. and Associated Company facilities that are impacted by regulatory requirements. PRINCIPAL ACCOUNTABILITIES: 1. Assure that validation of computerized systems is complete and meets regulatory expectations by: • Review and approve systems validation plans, protocols and reports, Software Development Life Cycle (SDLC) documentation and standard operating procedures for computerized systems and equipment. • Participate on computerized system project teams as the quality unit representative. • Support continuous improvement and remediation for areas identified by internal audit and planning. • Support the performance of validation master planning, audits and training. • Develop and maintain the Computer System Validation Master Plans for each Purdue operational facility. 2. Participate in the execution of a comprehensive annual internal audit plan across Purdue Pharma L.P. (and Associated Company) facilities for computerized systems and equipment consistent with company policies and standards, regulatory requirements (e.g. 21CFR Part 211, 21CFR Part 11), and industry standards (e.g. GAMP4). This may require as much as 20% travel. 3. Monitor and track applicable corrective and preventative actions resulting from the findings of audits. Perform verification of all completed corrective and preventative actions insuring that audit observations are satisfied. 4. Execute external vendor audits relating to computerized systems and equipment as required in support of GMP, GLP, and GCP operational activities. 5. Responsible for compliance with Controlled Substance and PDMA regulations as they apply to computerized systems and equipment. 6. Remain current on regulatory expectations and best practices through constant monitoring of changes to regulations, guidance documents, and industry trends related to the validation and qualification of computerized systems and equipment. Assess and interpret these expectations and best practices and provide recommendations on how to implement changes to Purdue policies and procedures to be consistent with the current trends.
Bachelors degree (BS preferred) and 10 plus years experience, or equivalent level of experience in pharmaceutical or related industries; or MS with 8 plus years experience or PhD with 4-8 plus years experience. A Computer Science or related degree is preferred. There is a need to understand information technology and details of systems development and operation.
Required Experience & Technical Requirements
Technical Requirements o Demonstrates strong knowledge of pharmaceutical regulations (GMP, GLP, GCP, Part 11) and a complete knowledge of the application of those regulations to computerized systems and equipment. o Experience in systems validation in the pharmaceutical environment and in systems auditing. o Excellent communication, negotiation and presentation skills.Brief Description/Overview:
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com. No hard copy resumes will be considered.
Purdue Pharma L.P. - 2 years ago