Quality Assurance Job at Apotex | Pharmacy Graduates Apply Now for the Executive Role
Apotex, a leading Canadian global health company, is hiring an Executive, Quality Assurance Operations to join their team in Bangalore, Karnataka. This Quality Assurance Job is centered around ensuring strict adherence to GMP and regulatory standards through key activities like IPQA (In-Process Quality Assurance), line clearance, materials sampling, and reviewing batch records. Candidates must hold a B.Pharm/Science degree and possess a minimum of 2 years of experience in a GMP-regulated pharmaceutical industry setting, ensuring quality throughout manufacturing and packaging stages.
- Job Title: Executive, Quality Assurance Operations
- Location: Bangalore, KA, IN, 560099
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.
Job Summary
- IPQA activities.
- Warehouse QA activities.
- MMaR’s / MPaR’s Review.
Executive Job Responsibilities
- Line clearance of various in-process stages such as Dispensing, Granulation, Compression, Coating, Packaging and Sampling.
- Routine monitoring of all functional areas to ensure adherence to the SOPs.
- Co-ordination & ensuring timely execution of sampling activity of raw and packing materials.
- Co-ordination of daily activities in manufacturing and packaging areas.
- Create signature and methods for raw materials by using Truscan RM analyzer.
- Approved / Rejected labels affixing for API, Excipients, Primary packing and secondary packing materials finished goods and operation supplies.
- Verification of temperature and relative humidity reports generated from TESTO software.
- Co-ordination & ensuring timely execution of in-process activities for manufacturing and packaging.
- Coordination for implementation of CAPA.
- In-process checks during manufacturing & packaging stage, performance of AQL, collection of samples as applicable and trending of AQL.
- Sampling of validation & commercial batch, Shelf life expiration date (SLED), Bulk completion date (BCD), sampling, Hold time study sample, In-process samples/Finished product samples, Collection, storage, and disposal of Reserve Sample.
- Preparation, review and updating of standard operating procedures.
- Planning, co-ordination, and sampling of raw and packaging materials.
- Co-ordination for process validation & cleaning validation execution.
- Approved/ Rejected labels affixing for API, Excipients, Primary and Secondary packaging materials.
- Swab/Rinse sampling for the cleaning verification & validation programme, cleaning & verification of sampling thief’s & accessories.
- Co-ordination for in-house and external calibration.
- Review of Master Manufacturing Records & Master Packing records & logbooks.
- Works as a member of a team to achieve all outcomes.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
Executive Job Requirements
Education:
- Bachelor of Pharmacy/ Science or any equivalent degree.
Knowledge, Skills, and Abilities:
- Should possess good communication and interpersonal skills along with computer proficiency in MS-Office and Internet.
Experience:
- Minimum 02 years of experience in GMP regulated pharmaceutical industry.
