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Regulatory Compliance Auditor II
Our Strength Is Our People. Passion. Principles. Perspective. At Watson, they're the traits that drive our growth and we apply them to every project and product. If you bring these qualities to your work, then we'd like you to consider joining our team.
Description:
Under general supervision, conducts internal Good Manufacturing Practice audits to assure compliance with Food and Drug Administration regulations and Company requirements.
• Carries out auditing responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Conducts internal audits at manufacturing and distribution facilities such as manufacturing, packaging, label control, storage, warehousing, distribution and laboratories to ensure compliance with Food and Drug Administration (FDA), current Good Manufacturing Practices (cGMP), EU regulations, ICH guidelines, Drug Enforcement Agency (DEA) regulations, departmental specifications and Standard Operating Procedures (SOPs).
• Interacts with corporate auditing group to ensure audits of site-specific vendors are scheduled and performed (external cGMP audits of raw material, packaging component and printed product vendors, suppliers and distributors as well as contract manufacturers, packagers and laboratories to compliance with FDA regulations, cGMPs, and SOPs).
• Composes and issues audit reports.
• Conducts internal compliance investigations utilizing approved protocols as applicable.
• Follow-up on internal and external audit action items as well as FDA commitments to ensure timely completion.
• Conducts internal cGMP audits for quality assurance functions.
• Participates in the resolution of issues found during audits in conjunction with quality assurance, manufacturing, regulatory affairs and research and development functions.
• Assists in FDA inspections and third party audits.
• Assists in preparing audit protocols as needed for internal compliance investigations or for cause audits.
• Researches current and developing regulations and attends training programs.
• Ensures project deadlines and performance standards are established and met.
• Ensures compliance with all Company policies and procedures, including safety rules and regulations.
• Develops implementation plans for new and changed corporate policies.
• Reviews information and documentation to determine compliance to standards (i.e. consultant’s qualifications, computer software vendor’s surveys, and manufacturer’s compliance review).
• Performs related duties as assigned.
Qualifications:
Two (2) to four (4) years pharmaceutical Quality Control, Quality Assurance or manufacturing
experience, of which one (1) year includes pharmaceutical auditing. ASQ Quality Auditor
certification and FDA Investigator work experience preferred.
For immediate consideration, please apply online at:
http://appclix.postmasterlx.com/track.html?pid=402881bd18074d530118e5f3ef1c718d&source=fda
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Position Type:
Employee
Ref Code: 5716BR |
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