Compliance Specialist - Pharmaceutica...
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Aug
24
Sandeep Singh Dhillon
Compliance Specialist – Pharmaceutical (Philadelphia, US)
Pharma Job Portal
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Job Description

Permanent position for a Compliance Specialist to conduct quality system audits ensuring compliance with SOPs and cGMPs. Perform Out of Specification (OOS) and nonconformance investigations in the analytical chemistry and manufacturing departments.
Assist QA department by maintaining and improving cGMP quality Systems.
Conduct Internal/external audits and prepare reports of analytical laboratory and manufacturing facilities.
Collaborate with all departments to develop and implement Corrective and Preventive Action (CAPA) plans. Observe and report effectiveness of CAPA plans.
Conduct Root Cause Analysis investigations and impact/risk assessments in response to deviations non-conforming events and audit observations
Prepare investigative test plans for non-conforming events.
Generate monthly metrics and quarterly trend reports for OOS investigation, non-conforming events and CAPAs.
Review change controls for impact and risk assessment

BS in Science related discipline
Minimum 3 years of experience in pharmaceutical manufacturing or related industry.
Experience conducting quality audits in an analytical laboratory or manufacturing environment.
Knowledge of cGMPs and FDA regulations related to analytical and pharmaceutical manufacturing practices.
Team player with excellent communication and interpersonal skills.
Experience with MS office software, including Word, Excel, Outlook.

Contact: Jessalyn Cotter

Please send all inquiries to [LINK: mailto:Jessalyn.Cotter@TerkoTech.com] Jessalyn.Cotter@TerkoTech.com

Apply here at http://jobs.terkotech.com/jobdetails//jobdetails/compliance-specialist-pharmaceutical-philadelphia-pa-us-19154/2006


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