Executive, Qms

6 months ago

Bengaluru Karnataka, India Apotex Inc. 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**:
A role-holder to drive the production process of [QMS-investigation-Deviation, Sunject Matter Expert(SME), Corrective Action & Preventive Action] to target the on-time production, delivery of product with quality compliance.

**Responsibilities**:

- To be Self-Disciplined & to maintain the same in the department.
- To maintain the safety and housekeeping practices at workplace.
- To be always ready to accept new challenges & multifunctional activities.
- To work as a lead investigator for deviation investigation and SME investigation related to production department.
- Perform independent investigation without any influence or bias.
- Perform all the necessary task to complete the investigation on time.
- Keep track of the investigation progress for completion.
- Timely communication to different stake holder on appropriate actions to support the investigation process.
- Conduct meeting/s with different SME to conclude the root cause and CAPA of the investigation.
- Ensure all the procedures are followed to complete the investigation.
- Always ensure that GxP practices are followed through the investigation.
- Take necessary actions to escalate any serious issue to the manager.
- Whenever required make relevant reports and presentations to support the department.
- Perform all work in support of our Corporate Values of Courage, Passion, Collaboration and Perseverance; Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviors 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**:

- B.Pharm
- **Knowledge, Skills and Abilities**:

- Critical thinking in handling of deviations, SME investigation, CAPA records.
- Knowledge of cGMP practices
- Closing of deviations, SME investigation, CAPA and temporary change record within the due date
- **Experience**:

- Fresher

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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