Executive, QA Operations, Ipqa

3 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**:

- IPQA activities.
- Warehouse QA activities
- MMaR’ S / MPaR’s Review.

**Responsibilities**:

- Line clearance of Various in process stage such as Dispensing, Granulation, Compression, Coating, Packaging and Sampling.
- Routine monitoring of all functional area 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 procedure.
- 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.
- Preparation for regulatory audits and making the compliance for the same.
- To ensure that the impact of any risk reduction measures is not detrimental to the systems, facilities, utilities, equipment, or processes.
- Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values - Collaboration, Courage, Perseverance and Passion.
- Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
- All other duties as assigned.

**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 efficacy in MS-Office and Internet
- **Experience**:

- Minimum 02 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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