Executive, QA Validation

2 weeks ago

Bengaluru Karnataka, India Apotex Research Private Limited Full time

**About Apotex Inc.**

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

**Job Summary**:
**Responsibilities**:

- **Cleaning Validation**:

- Responsible for evaluation of products for cleaning validation, preparation of cleaning validation matrix, performing MACO calculation, preparation of Equipment Cleaning Process Design Document (ECPDD),.cleaning validation protocols and reports, Quarterly/Annual monitoring reports for cleaning validation
- **Process Validation**:

- Responsible for review of documents related to process validation for demonstration batch, Optimization batch, Technical Risk Assessment, Process Performance Qualification, packaging validation protocols and reports, Continuous process verification and hold time study protocols and reports.
- Knowledge on equipment qualification is a must

**Job Requirements**:

- Education:

- Master degree in Pharmacy
- Knowledge, Skills and Abilities
- Possess sound knowledge in process & cleaning validation activities.
- Maintains good Interpersonal skills and communication skills.
- Should complete the activities with right first time approach.
- Experience
- Minimum 6-7 years of experience in GMP Regulated pharmaceutical industry

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers 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.

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