Client of Cygnus Staffing Solutions, a Leading Group of Companies, into Manufacturing of Herbal Products & Spices looking for
? Good manufacture/laboratory/engineering practice.
? Preparation of validation protocols & Reports.
? Participate in validation activities
? Review of equipment / instrument validation
? Ensure quality compliance in manufacturing & Engineering.
? Quality System Compliance & Vendor Audits
? Internal & External Audit Participation & Compliance.
? Monitoring and review of PMPs and calibration of equipments/instruments.
? Review of trends for raw/potable and purified water system.
? Execution of PLC Qualification activities
? Handling of drawings and updating.
? Issuance and Control of Documents/ Records
? Vendor audits and vendor qualification
? Issuance, Control and Retrieval of GMP Documents (SOP’s, Master and Executed GMP documents) through Manual and Electronic (DMS) Document Management systems
Qualifications & Validation
Preparation of Protocols, Report, Execution, review, Compilation and closing out.
? HVAC (Heating, Ventilation and Air conditioning) system Qualification
? Equipments (IQ, OQ & PQ)
? Purified water system
? Quality Control and Microbiology Equipments/Instruments.
? Packaging Validation
? Re - Validation (Equipments / HVAC)
? Compressed air system
? Preparation & Updating of SMF & VMP
? Handling of Incidents, deviations and documentation activities.
? Preparation of SOP's
? Cleaning validation
? Process validation
VALIDATIONS RELEVANT TO MICROBIOLOGY:
? Process Simulation Study (Media Fill).
? Autoclave, Bung processor (Mchine Fabric)
? DHS Validation. (Challenge test with Endotoxin indicators).
? Method validation of bacterial endotoxin test.
? Review of Summary reports of Microbial method validations.
? LAF Validation
? Disinfectant validation.
? Method validation of sterility.
? Proficlave validation.
? BioQuellQube (isolator) validation.
INSTRUMENTS AND EQUIPMENTS HANDLED
? LBPC analyzer (LIQUILAZ).
? Air samplers (Merck).
? Autoclave (machine fabric).
? Media sterilizer
? Media dispenser.
? BioQuellQube (isolator).
? Blister packing machine (ELMAC 3015)
? Bottle packing line (pharma pack)
? Sachet filling machine (pakona)
? Malti mill and RMG
? Compression machine
Qualifications & Experience :
BSC / MSC -Microbiology
Experience ; 3 to 6 years
Job location ; Shamirpet,Hyderabad
Salary ; Negotiable
Cygnus Staffing Solutions
emai ; cygnusresumes(AT)gmail.com (AT = @)