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