New job GMP Expert Consultants-Philadelphia Area

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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: GMP Expert Consultants-Philadelphia Area Robert Ciociola posted a job: GMP Expert Consultants-Philadelphia Area "Contract Position-24 months Send resumes to :bciociola@covexllc.com Travel: May require up to 10% travel Leadership Responsibilities: The person will lead cross-functional team at the site, but no direct line management responsibilities This contract is for approximately a 24-36 month period. Job Description: Provide guidance to the teams relative to GMP and GDP compliance and industry best practices in Manufacturing and Distribution in the following areas: • SOP clarity and alignment of requirements in the Company Quality Standards, Enterprise Quality Standards and GMP’s • Assure that the SOP’s and associated revised processes comprehensively address findings and • Good Documentation Practices • Investigations: clarity, completeness, root cause determination, corrective actions, preventative actions, timeliness • Training: Ensure training content is defined and executed per role/ • Change Controls: Provided mentorship within the change control process. • Ability to review complex data, and provide professional recommendations, where needed. • Metrics design, review, trending and continuous improvement response • • Provide guidance and assist in corrections required to produce a GMP compliant documentation of remediation work. • Provide GMP/ Quality Assurance/ Quality Systems guidance in the development of effective and efficient Quality Systems. • Establish training on Lessons Learned from identification of areas of GMP improvement opportunities. Most important skills and competencies for the position: 1. 10 years of relevant experience with increasing responsibility in the pharmaceutical or medical device industry 2. Experience in a Consent Decree preferred or FDA remediation experience 3. Blackbelt or ASQ certification. Six Sigma experience 4. Change controls experience is a must 5. Bachelor's Degree in Physical Sciences, Engineering, or a related discipline"

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