Junior Manager-PSV Quality
Date: Sep 23, 2025
Location: Bangalore, KA, IN, 560099
Company: Apotex
About Apotex Inc.
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.
For more information visit: www.apotex.com.
Job Summary
Preparation, review and reporting of process and cleaning validation studies, APQRs & trending. Review of equipment/ support system qualifactions, calibrations and production support activities.
Job Responsibilities
- Validation studies.
- Preparation of Annual quality product review & Cleaning verification periodic review ..
- Review of the excuted BPCR's /GCR's and Manufactiring related documentation support.
- Supporting and co-ordinating for dispatch activities.
- To perform the SAP related activities.
- To perform viable sampling for environmental monitoring activities.
- Preparation of trending reports for key starting materilas, intermediates and finished products.
- Performing daily production activities like plant rounds, equipment visual cleaning clearance & RMDC release.
- Preparation and revision of the Departmental SOP's, Form's and exhibits.
- Monitoring of the cGMP compliance through Plant rounds.
- Documentation & issuance activities.
- To perform unannounced audits.
- To review and take retained sample area temperature printouts.
- Review of alarm summary and audit trail report in data logging system (PiSCADA).
- Handling eResidue pro application.
- Preparatoin of quality risk assessment reports and other related activities.
- Preparation of validation master plan and exhibits.
- Handling of QMS activities in trackwise (change control).
- Review of equipment/ support system qualification documents.
- Review of calibration certificate and monitoring of preventive maintanace activities.
- Preparation of Quality trending documents for OM water, environmental monitoring and nitrogen trending etc.
- To co-ordinate with the manufacturing team to address any Quality issues arises during manufacturing.
- To adhere the EHS policy & procedure in routine activities.
- To involve in EHS related activities on need basis.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
Job Requirements
- Education
- Minimum Masters Degree in Science /Pharmacy
- Minimum Masters Degree in Science /Pharmacy
- Knowledge, Skills and Abilities
- Knowledge of Relevant procedure and applicable regulatory guidelins.
- Knowledge of cGMP activities.
- Knowledge on API Manufacturing activity.
- Knowledge on relavent applications.
- Experience:
- 9.0 years of experience in Quality Assurance & Compliance functions.
At Apotex, we are committed to fostering a welcoming and accessible 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.