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| Job Location | Mysore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Recruitment Services |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Position: AM Quality ControlDepartment: Nicotine Extract ProjectExperience: 8- 10 YearsQualification: M. Sc. Organic / Analytical/ Pharma ChemistryLocation: Guntur (Andhra Pradesh)Roles & Responsibilities :Hands on experience in sophisticated instruments like HPLC, GC, GC- MS, UPLC- MS, Malvern, TOC for testing of sample for Purity, impurity etc. Knowledge and practical experience on QMS documentation like change control, lab incidents, OOS, OOT, investigationsExperience on liquid extract sample analysis on different instrumental methodsKnowledge of Analytical Method Validations, computer system validations Instrument Qualification in line with regulatory requirementsAwareness of 21 CFR part 11 requirements including User Management Policies, audit trail review etc. Exposure to regulatory inspections like USFDA, EDQMConduct risk assessment and enforce SOPsShould be good reviewer of analytical documentsSampling and testing of raw materials, intermediates and finished products using current pharmacopoeias, any associated wet chemistry and instrumental techniques (HPLC, IR, UV), as appropriate. Preparing Quality reports, including analytical reports (for raw materials and finished products), Certificates of Analysis (CoA) (for finished products) and stability reports. Creating and executing method development and method validation test protocols for finished products and generating the appropriate analytical methods. Stability testing of products for new formulations and ongoing stability trials, using physical (pH, viscosity) and instrumental (HPLC, UV) techniques, as appropriate. Writing analytical specifications using current pharmacopoeias and reviewing existing analytical specifications. Writing/ reviewing Standard Operating Procedures (SOPs). Calibrating analytical equipment, as and when required. Supporting all QC activities. Ensuring that procedures are carried out carefully and accurately to eliminate errors. Working with all members of staff to maintain and develop the positive progressive culture within The Specials Laboratory. Observing and complying with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP). Observing and complying with company Health and Safety Policies. Observing and complying with company Standard Operating Procedures (SOPs). Candidate should have understanding on procurement of lab material like chemicals, instruments through SAP ,
Keyskills :
ser management method validation finished products raw materials 21 cfr audit trail wet chemistry continuous improvement facilitation stability testing risk assessment standard operating procedures change control