Job Title:
Manager, Quality Control
Date Posted: August 19, 2025
Location: Bangalore, Karnataka, India, 560099
Company: Apotex
Company Overview:
Apotex Inc. is a Canadian-based global healthcare company specializing in high-quality, affordable medicines. With nearly 6,000 employees worldwide, Apotex manufactures and develops generic, biosimilar, and specialty products available in over 70 countries. The company is vertically integrated and focused on innovation and global accessibility.
Website: www.apotex.com
Job Summary:
Manage and oversee analytical activities, instrument calibration/qualification, investigations, and documentation within the Quality Control department at Apotex Research Pvt. Ltd.
Key Responsibilities:
Report daily activities to the Head of Quality & Compliance and Head of Quality Control.
Ensure Quality Control Laboratory operations follow established standard procedures.
Identify and fulfill training needs of departmental employees.
Support Manufacturing Operations during exhibit and commercial batch executions within timelines.
Assess, review, approve, and ensure timely completion of QC department changes per change control procedures.
Monitor timely analysis of commercial samples.
Coordinate with service engineers for the maintenance and smooth functioning of laboratory instruments.
Review and approve SOPs and testing directions for laboratory samples.
Conduct investigations of Out of Specification (OOS) and Out of Trend (OOT) results; identify assignable causes and ensure timely resolution.
Evaluate and approve investigations, deviations, CAPAs, and change control records.
Maintain disciplined work environment and provide expertise to colleagues for proper laboratory procedure performance.
Interface with QA and auditors during regulatory inspections and audits.
Assist with activities like data compilation for Annual Product Quality Review (APQR), training, vendor development, self-inspections, and external audits.
Support handling of market complaints, product recalls, and quality-related returns in coordination with Apotex affiliates.
Keep updated on latest cGMP, GLP, and regulatory requirements and train team accordingly.
Lead performance management activities including monthly one-on-one meetings, supporting employee development, and reinforcing company values.
Foster a culture of trust, employee development, and high performance aligned with core values: Collaboration, Courage, Perseverance, and Passion.
Attract, hire, onboard, and retain talent to support company growth.
Ensure compliance with company policies and regulatory programs among team members.
Perform other duties as assigned by senior management.
Education:
Minimum MSc or B.Pharm or equivalent degree.
Skills & Abilities:
Excellent verbal and written communication skills.
Strong interpersonal skills.
Proficient in MS Office tools.
Knowledge in preparing and reviewing SOPs, formats, protocols, reports, and analytical data.
Experience in investigation and deviation report preparation.
Proficient in troubleshooting instruments and analytical methods.
Thorough knowledge of regulatory guidelines and cGMP activities.
Strong prioritization and effective planning skills to meet deadlines.
Experience:
Minimum 16 to 20+ years of experience in GMP-regulated pharmaceutical industry.
Equal Opportunity & Accessibility:
Apotex is committed to an inclusive and accessible work environment. Accommodations are provided for applicants with disabilities throughout the recruitment process. Please inform if accommodations are needed during interview or testing.
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