5 - 9 years

0 Lacs

Posted:1 day ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a QA/QC Manager at our company, you will be responsible for liaising between various departments such as Planning, Production, Technical Services, Marketing, and Exports. Your role will involve the following key responsibilities: - Preparation, review, and implementation of SOPs and STPs. - Checking of all QC related records like analytical reports and logbooks. - Planning and distribution of samples for analysis of Raw Materials, Intermediates, and finished products. - Designing and conducting Stability studies as per ICH Guidelines. - Developing and validating analytical testing methodology used to control raw materials, production intermediates, and final products. - Preparation and maintenance of working standards with documents. - Operation & Calibration of the laboratory instruments like HPLC, GC, and Spectrophotometer. - Reviewing and approving Raw material, finished product, and Packaging material specifications. - Handling customer audits and regulatory authority audits and preparation of compliance reports. - Troubleshooting of HPLC, GC, & other instruments. - Laboratory management and analytical laboratory improvement, cGMP, and GLP compliance and problem resolution. - Sole responsibility for exports and quality related issues for the unit. - Supervision of QC chemists for the smooth working of the department. - Ensuring the best quality of products from production. Qualifications required for this role: - Bachelor's degree in a relevant field (e.g., Chemistry, Pharmacy, etc.). - Minimum of X years of experience in QA/QC roles in the pharmaceutical industry. - Strong knowledge of cGMP guidelines and regulatory requirements. - Experience in handling customer and regulatory audits. - Proficiency in analytical instruments like HPLC, GC, and Spectrophotometer. Location: Byrathi, Bangalore (Note: No additional company details were provided in the job description.),

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