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Document Reviewers
Location:
Markham
Description:
Shields Pharma Inc. is looking for qualified and experienced employees to join the successful team. We currently have the following full time positions available for Markham, Ontario: Document Reviewers Responsibilities: • Perform timely data review (including drug substances, excipients, in-process materials, drug products, stability, analytical method validation documentation, microbiological testing etc. ) to ensure accuracy, completeness and compliance with GLP, GMP, all applicable SOPs and regulatory requirements. • Perform internal audits ensuring the lab operations are carried out according to approved procedures and in accordance with GMP/c GMP requirements. • Review laboratory notebooks for incoming samples, standards, reagents, equipment etc. • Issue and reconcile controlled laboratory notebooks and other GMP documentation. • Archive and retrieve laboratory data and reports. • Periodic review of training records, SOPs, change control implementation, deviation and OOS investigations. • Prepare for and participate in client audits and regulatory inspections as required. • Oversee data review, documentation, C of A preparation activities as required. • Perform other tasks as required. Education and Experience: • University degree in Science – preferably in Chemistry with experience in the review of data from chemistry and microbiology laboratories. • A minimum of 3 years Quality Assurance Document Reviewing experience in a regulated environment• Strong understanding of quality systems, Canadian, US, EU GMP requirements. • Knowledge of Compendia, analytical techniques and method validation. • Excellent verbal and written communication skills; and interpersonal skills. • Extremely results driven and organized. The above positions are only applicable to permanent residence and/or Canadian citizens with a minimum degree in science. To apply, please reference “Document Reviewer” in subject line and submit resume and cover letter with. Visit ListedBuy for more information.
Company:
Shields Pharma
Posted:
April 23 on ListedBuy
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More About this Listing: Document Reviewers
Document Reviewers is a Science, Pharmaceutical & Biotech Jobs Document Reviewers Job at Shields Pharma located in United States. Find other listings like Document Reviewers by searching Oodle for Science, Pharmaceutical & Biotech Jobs Document Reviewers Jobs.
Document Reviewers is a Science, Pharmaceutical & Biotech Jobs Document Reviewers Job at Shields Pharma located in United States. Find other listings like Document Reviewers by searching Oodle for Science, Pharmaceutical & Biotech Jobs Document Reviewers Jobs.