Pharmaceutical Quality Assurance- Assistant Manger​/Senior Executive

Pharmaceutical Quality Assurance – Assistant Manager / Senior Executive

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

• Well versed in the analytical review which includes review of GLP, lab support systems like column management, standard handling, retention sample management, stability management & review of stability protocol/summary sheet.
• Computer system validation and calibration & qualification of instruments.
• Review of audit trail.
• Ensure all time laboratory compliance.
• Handling of QMS records like OOS/OOT, CAPA, deviation and making the trend reports.
• Review of analytical documents which include worksheet, chromatograms, AMT/AMV.
• Preparation, review of specification & STP.
• To review the analytical reports in support of batch release activities.
• To review batch records and manage the batch release activities.
• Check rounds of lab and internal auditing.
• Leading the group independently in the absence of Manager for planning and coordinating with other functions (CFT).
• Act as AQPIC for controlled substances.

• 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.

• Role is expected to work in all shifts.
• Expected to visit other sites on need basis.

Seniority level
:
Mid-Senior level

Employment type
:
Full-time

Job function
:
Quality Assurance

Industries
:
Pharmaceutical Manufacturing