Senior Research Associate-AD Piramal Finance

1.0 - 4.0 years

3 - 6 Lacs

Ahmedabad

Work from Office

Prepare trending of Events/Incident and ensure completeness of its closure. Identify the gaps and provide appropriate training to analytical scientist to strengthen compliance level. Thorough review of clinical batch release data, method validation protocol & report, clinical stability sample analysis, as per cGMP and regulatory requirement. Ensure review of daily verification/calibration of pH meter, balances and TOC. Ensure review of calibration record of all analytical instruments and update of calibration planner in timely manner. Thorough review of method development report and investigation study report Randomly review and cross verify all analytical instrument logbook entries and laboratory notebook for its completeness for compliance point of view. Randomly review of standard, column and chemical management logbooks. Ensure in-house compliance system. Randomly review of QMS activities (i.e. change control, incident, deviation). Maintain hygienic condition in laboratory. Follow GxP (GMP, GDP, GLP) for all processes. Ensuring proper use of Personal Protective Equipment. Thorough review of IQ/OQ and PQ of instrument/equipment. Ensure computer System Validation according to CSV SOP and identify gap in qualification document according to CSV SOP. Perform internal audit of AD and provide appropriate training to AD team. Accompany the internal audit and provide appropriate response to audit observations. Training on GDP/GLP/DI to the scientist on quarterly basis to ensure compliance. Tracking and monitoring of calibration planner and preventive maintenance planner. Responsibilities Qualifications M. Pharm/ M.Sc. Chemistry

Posted 12 hours ago

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WALK-IN Interview - Executive / Sr. Executive - Microbiology Micro Labs

2 - 7 years

3 - 7 Lacs

Bengaluru

Work from Office

We are hiring for multiple position in Microbiology Dept. Contact person Mr. Srinivasa M, those who are unable to attend the interview are requested to forward their resumes to email id: naveenkumarp@microlabs.in, jonesnaveenrajp@microlabs.in Candidates are requested to carry their copies of Resume, Mark Sheets, Experience Certificates, Latest salary certificate, pay slips of three months and one photographs. MICROBIOLOGY Dept: Position: Sr.Officer/ Executive / Sr. Executive ( Only for male candidates) Qualification: B.Sc/ M.Sc- Microbiology/ BioTech Experience: 2-8 years experience in Sterile Manufacturing facility. Job Profile: Microbiology Analytical Activities (MLT, BET, Stability), Environmental monitoring, QMS activities in sterile manufacturing facility.

Posted 1 month ago

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Development QA Executive - API Sekhmet Pharmaventures

2 - 4 years

4 - 6 Lacs

Hyderabad

Work from Office

Role & responsibilities Review of Analytical method validation, method transfer and method verification protocols & reports. Review of method development reports. Review of Stability & Holding Study analysis data. Review of equipment qualification /calibration/ validation reports (IQ, OQ, PQ) related to all analytical instruments. Should have knowledge on review of Specifications & Standard test procedures. Review of reference standard and impurity COAs and characterization data. Should have knowledge of GTI & Nitrosamines risk assessment. Responsible for issuance and archival of documents. Should have good knowledge of ICH guidelines, USP general chapters. Should have knowledge of QMS activity (Incidents, Change controls). Review of Empower and other analytical instruments audit trails. Responsible for maintaining GLP & GDP at the workplace. Excellent written and verbal communications skills. Preferred candidate profile

Posted 1 month ago

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