Assistant Manager - Quality Control Testing

APOTEX; Bengaluru; On-site; INR 2,000,000 - 2,800,000; Full time

Job summary

Apotex in Bengaluru, India, is seeking an Assistant Manager - Quality Control Testing to oversee validation, environmental monitoring, and QC documentation in a fast-paced pharmaceutical manufacturing environment.

The role demands strong knowledge of cGMP, ICH Q7 and experience with regulatory inspections (USFDA, TGA, MHRA). 9–12 years of relevant experience and meticulous attention to data integrity are required.

Qualifications

• To Follow cGMP and ICH Q7 guidelines.
• Experience with regulatory inspections (USFDA, TGA MHRA, etc).
• 9 to 12 years of relevant QC experience.

Responsibilities

• Preparation of process validation protocol, cleaning validation protocol and cleaning evaluation report, trending and establishment of LCL and UCL, APQRs and VMP supporting documents.
• Preparation of trending reports (raw materials, intermediates and finished API) as per the schedule.
• Re-evaluations, Temperature Mapping, Equipment change controls, DM water validation, Environmental Monitoring, Calibration & Preventive Maintenance activities.
• Preparation, review of protocols and reports for Equipment, Support system qualification.
• Execution and monitoring of Environmental monitoring Programs.
• Execution and monitoring of Temperature mapping study.
• Monitoring of Preventive Maintenance activities.
• Review of the executed BPCR’s /GCR’s and Manufacturing related documentation support.
• To ensure manufacturing documents are issued/archived as per procedure in line with manufacturing activities.
• To monitor and ensure the Dispatch activities initiated after the Quality release.
• Equipment and area clearance certification for product changeover.
• SAP transactions.
• Review of Analytical Test Data Sheets & Tests Reports for finished products, Intermediates, impurity standards and reference standards.
• Preparation of certificate of analysis for impurity standards and reference standards.
• Quality Control Laboratory rounds for monitoring online GLP compliance.
• IPQA Activities in Manufacturing & Packing

Skills

cGMP knowledge

ICH Q7

Regulatory inspections

Education

M.Sc. / M. Pharma

Tools

SAP

Job description

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Assistant Manager - Quality Control Testing

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

The position entitles the incumbent to possess adequate practical and technical knowledge on the Quality control techniques and related instruments.

Job Responsibilities

• Preparation of Process validation protocol, Cleaning validation protocol and cleaning evaluation report, trending and establishment of LCL and UCL, APQRs and VMP supporting documents.
• Preparation of Trending reports (Raw materials, Intermediates and Finished API) as per the schedule.
• Re-evaluations, Temperature Mapping, Equipment change controls, DM water Validation, Environmental Monitoring, Calibration & Preventive Maintenance activities.
• Preparation, Review of protocols and reports for Equipment, Support system qualification.
• Execution and monitoring of Environmental monitoring Programs.
• Execution and monitoring of Temperature mapping study.
• Monitoring of Preventive Maintenance activities.
• Review of the executed BPCR’s /GCR’s and Manufacturing related documentation support.
• To ensure manufacturing documents are issued/archived as per procedure in line with manufacturing activities.
• To monitor and ensure the Dispatch activities initiated after the Quality release.
• Equipment and area clearance certification for product changeover.
• SAP transactions.
• Review of Analytical Test Data Sheets & Tests Reports for finished products, Intermediates, impurity standards and reference standards.
• Preparation of certificate of analysis for impurity standards and reference standards.
• Quality Control Laboratory rounds for monitoring online GLP compliance.
• IPQA Activities in Manufacturing & Packing

Job Requirements

• Education:
  • M.Sc. / M. Pharma
• Knowledge, Skills and Abilities:
  • To Follow cGMP, Knowledge on ICH Q7, Experience in regulatory inspection like USFDA, TGA MHRA etc
• Experience:
  • 9 to 12 Years

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.