Trainee, Quality Cnt-arpl-qcst Ar

1 week ago

Bengaluru, India Apotex Research Private Limited Full time

**About Apotex Inc.**

**Job Summary**:
Method verification/validation of compendia/pharmacopeial updations, Method verification of SDC’s (Supplier Driven Changes) method. Method validation of cleaning verification, Preparation of method verification and validation protocols and reports, Evaluation of SDC, compendial/pharmacopeial updations, Preparation of In-House method and Specification. Analysis of raw material and excipients.

**Responsibilities**:

- Analysis of Compendia, raw material samples, Analytical method transfer samples as per method of analysis by adhering to the regulatory procedures.
- Preparation and review of Memo, Method Verification/ Method validation protocols, Method Verification/Method validation reports, Method transfer summaries.
- To involve in investigations and excursions as per SOP, to provide technical support during investigations of OOS/OOT results and to identify assignable cause.
- Compendia changes review, method verification.
- To perform the cleaning validation as per the protocol.
- Perform all work in accordance with all established regulatory and compliance and safety requirements.
- Responsible for preparation and updating of specification and method of analysis as per regulatory requirements and compendia requirements.
- To be responsible for all activities in the Quality control Laboratory, including cGLP, documentation and implementation of departmental quality system as and when required.
- To generate and maintain records related to laboratory samples.
- 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**
- MinimumMSc/BPharm or any equivalent degree.

**Knowledge, Skills and Abilities**
- Command on Microsoft-Office (Word, Excel).
- Able to prioritize the tasks.
- Best in effective planning of work activities to meet the time lines.
- Able to perform multi parameter analysis on HPLC instrument.

**Experience**:

- Minimum 2 to 4 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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