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.