
Quality Assurance Manager
3 days ago
Job Description
">- Perform analytical activities as per the defined competency matrix and provide on-job training and practical demonstration for chemical and instrumentation.
- Analyze in-process, SFG, finished goods, raw material, and stability samples, along with analytical method validation/verification of OSD and LVP according to the defined protocol or procedure and related documentation as per GLP and GMP within the given timeframe.
- Receive samples and their documentation.
- Enter data into SAP.
- Send samples to outside laboratories for analysis as required by the commercial lab.
- Calibrate instruments as needed.
- Prepare volumetric solutions, reagents, and test solutions when necessary.
- Maintain timely updations in documents as per Pharmacopeial amendments.
- Ensure resource maintenance in the quality control department.
- Evaluate the compliance of cGDP/cGDP requirements while performing all laboratory activities.
- Adhere to EPD Global Guidelines.
- Face internal and external audits and ensure compliance.
- Implement GLP/GMP requirements.
- Coordinate and align practices and procedures according to COBC standards.
- Provide SOP training in Isotrain or self-train within stipulated time frames.
- Perform any other tasks assigned by the reporting manager.
- In the absence of the position holder, a subordinate executive or manager will be responsible for day-to-day operations.
Required Skills and Qualifications
">- Strong analytical skills with attention to detail.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a team environment.
- Familiarity with SAP software.
- Knowledge of GLP and GMP principles.
- Understanding of cGDP/cGDP regulations.
- Basic understanding of pharmacopeial amendments.
- Able to maintain accurate records.
Benefits
">- Opportunity to work in a dynamic and challenging environment.
- Professional growth and development opportunities.
- Collaborative and supportive work culture.
Others
">- The selected candidate will undergo rigorous background checks and must adhere to strict confidentiality agreements.
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