11 Oct
|
MEDITEKINDIA
|
Mangalore
11 Oct
MEDITEKINDIA
Mangalore
Roles and Responsibilities
- Sampling & Analysis: Sampling of raw materials, in-process materials, finished products and packaging materials as per approved SOPs; performing chemical, physical and instrumental testing as per Pharmacopoeia standards and in-house specifications; conducting analysis of water samples; ensuring proper labelling, handling and traceability of all samples and test materials.
- Instrument Operation & Maintenance: Operating analytical instruments; performing calibrations; maintaining instrument logbooks and ensuring all instruments are in a validated state before use.
- Documentation & Reporting: Recording all observations and analytical data accurately in analytical worksheets and logbooks as per GDP; preparing and reviewing Certificates of Analysis (CoA) for approval and release; maintaining and updating STPs, SOPs and specification records; ensuring timely reporting of test results and communicating any abnormal findings to superiors.
- Stability Studies: Conducting stability testing of products as per ICH guidelines; ensuring proper placement, withdrawal and testing of stability samples; recording, compiling and reporting stability data.
- Reagent & Solution Management: Preparing and standardising volumetric solutions, reagents, mobile phases and buffers as per SOP; labelling all prepared reagents with preparation and expiry dates; ensuring proper storage and disposal of chemicals and waste as per EHS guidelines.
- Compliance & Quality Systems:
Adhering strictly to GLP and GMP at all times; following approved SOPs, test methods and safety protocols; assisting in investigation of OOS, OOT and deviation reports; maintaining cleanliness and environmental control of laboratory areas.
- Coordination & Communication: Coordinating with Production, QA and Warehouse teams for sampling and release activities; reporting non-conformities and analytical abnormalities immediately to the QC Manager.
Key Competencies:
- Raw Material, In-Process & Finished Product Testing
- Pharmacopoeia Methods - IP / BP / USP / EP
- HPLC Method Execution & System Suitability
- Certificate of Analysis (CoA) Preparation & Review
- Stability Testing as per ICH Guidelines
- OOS / OOT Investigation & CAPA Support
- Reagent Preparation, Standardisation & Inventory
- GLP / GMP / GDP Compliance in QC Operations
Qualification:
- M. Pharm (Pharmaceutics / Quality Assurance /Pharmacognosy) - Preferred
- M.Sc. (Pharmaceutical / Industrial / Applied Chemistry) with 0-2 years of relevant experience
- B. Pharm with 1-2 years of relevant experience in QC in an OSD pharmaceutical environment
- Work Experience: 0-2 years in QC/ Analytical laboratory in Pharma / Nutraceutical manufacturing.
Interested candidates can apply through E-mail: [email protected] or whatsapp to: (phone hidden)
Pay: ₹276,000.00 - ₹300,000.00 per year
Advantages
- Food provided
- Health insurance
- Provident Fund
Work Location: In person
📌 Quality Control (Mangalore)
🏢 MEDITEKINDIA
📍 Mangalore