Pharmaceutical Quality Assurance- Assistant Manger/Senior Executive

Job Description

<p>Job Description</p><p>Purpose</p><p><em>To support Canada R&D Lab and North American Quality Operations</em></p><p>Position / Job Title</p><p><em>Sr. Executive / Asst. Manager</em></p><p>Department</p><p><em>Quality Assurance</em></p><p>Reporting To</p><p><em>Sr. Manager – Quality Assurance</em></p><p>Location</p><p><em>Canada</em></p><p>Years of Experience</p><p><em>5 to 7 Years</em></p><p>Dosage Form</p><p><em>Solid Oral / Liquid/ Nasal ( preferred)</em></p><p>Job Responsibilities / Deliverables</p><p><em>1) Well versed in the analytical review which includes review of GLP, Lab support systems like Column management, Standard handling,</em></p><p><em>2) Retention sample management, stability management & review of stability protocol/summary sheet</em></p><p><em>3)Computer system validation and calibration & qualification of instruments</em></p><p><em>4) Review of audit trail.</em></p><p><em>5) Ensure all time laboratory compliance.</em></p><p><em>6) Handling of QMS records like OOS/OOT, CAPA, Deviation and making the trend reports.</em></p><p><em>7) Review of analytical documents which include worksheet, chromatograms, AMT/AMV.</em></p><p><em>8) Preparation, Review of specification & STP.</em></p><p><em>9) To review the Analytical reports in support of Batch release activities</em></p><p><em>10) To review batch records and manage the batch release activities</em></p><p><em>11) Review Analyst qualification data</em></p><p><em>15) Check rounds of lab and internal auditing</em></p><p><em>16) Leading the group independently in the absence of Manager for planning and coordinating with the other functions (CFT)</em></p><p><em>17) Act as AQPIC for Controlled substances</em></p><p>Qualifications & Pre-Requisites</p><p><em>Must-Have Skills:</em></p><ul><li><em>Must have knowledge on handling HPLC</em></li><li><em>Exposure to various regulatory bodies like US FDA, Health Canada</em></li><li><em>QMS Management and hands-on with Laboratory investigations</em></li><li><em>Team coordination and work distribution</em></li><li><em>Commercial Batch Release activities</em></li></ul><p>Additional notes</p><ul><li><em>Role is expected to work in all shifts.</em></li><li><em>Expected to visit to other sites on need basis.</em></li></ul>