pharma quality assurance manager
4 days ago
A WHO GMP CERTIFIED MANUFACTURER OF DRUG FORMULATIONS IN EXTERNAL PREPARATION AND ORAL LIQUID FINISHED DOSAGES LOOKING FOR PHARMA QUALITY ASSURANCE MANAGER (PHARMACEUTICAL MANUFACTURING) HAVING THE BELOW SKILLS AND QUALIFICATIONS.
A. MINIMUM WORK EXPERIENCE OF 7 YEARS IN PHARMACEUTICAL MANUFACTURING QUALITY ASSURANCE REQUIRED.
B. MINIMUM BACHELOR OF SCIENCE OR PHARMACY DEGREE REQUIRED.
IN ADDITION TO THAT HANDS-ON, STRONG AND THOROUGH KNOWLEDGE OF THE BELOW PRIMARY SKILL SETS ARE REQUIRED.
WHO GMP NORMS
PHARMA REGULATIONS
PHARMA QUALITY MANAGEMENT SYSTEM
PERFORMING VALIDATION, CALIBRATION & QUALIFICATIONS OF MACHINES, EQUIPMENTS, INSTRUMENTS & TOOLS
PERFORMING ALL TYPES OF PROCESS VALIDATION
PERFORMING AREA VALIDATION
PERFORMING WATER VALIDATION
PERFORMING CLEANING VALIDATION
PERFORMING HOLD TIME STUDY
PERFORMING ALL TYPES OF VALIDATIONS & CALIBRATIONS FALLING UNDER PHARMA MANUFACTURING PLANT
DEVELOPING AND MAINTAINING DETAILED STANDARD OPERATING PROCEDURES, BATCH MANUFACTURING RECORD, BATCH PROCESSING RECORD & MASTER FORMULA RECORD
DEVELOPING AND MAINTAINING SITE MASTER FILE
DEVELOPING AND MAINTAINING ALL TYPES OF DETAILED DOCUMENTATIONS FALLING UNDER PHARMA QUALITY ASSURANCE, QUALITY CONTROL, PRODUCTION, ENGINEERING & STORE DEPARTMENTS
PREPARING ERROR FREE CTD DOSSIER
SEARCHING IN AND UNDERSTANDING PHARMACOPEIA
DRAFTING OF APPLICATIONS OF PRODUCT LICENSES, CERTIFICATE OF PHARMACEUTICAL PRODUCTS AND FREE SALE CERTIFICATES ETC
REVIEWING ARTWORK AS PER THE REGULATORY NORMS AND MAKING REQUIRED CORRECTIONS
PERFORMING IN PROCESS QUALITY ASSURANCE ACTIVITIES
FACED AND SUCCESSFULLY HANDLED COUNTRY SPECIFIC AUDITS
IN DEPTH KNOWLEDGE OF PHARMASUITE ERP
EFFECTIVELY USE MICROSOFT WORD, MICROSOFT EXCEL & EMAIL
APPLICANT SHOULD BE TRUSTWORTHY, PUNCTUAL, EFFICIENT, ORGANIZED, HARD WORKING, ANALYTICAL, DETAIL ORIENTED AND TEAM PLAYER.
WORKING DAYS:- WEDNESDAY THROUGH MONDAY
WORKING HOURS:- 9:30 AM TO 6:00 PM
HOLIDAY:- EVERY TUESDAY
JOB LOCATION:- CHANGODAR 382213, DISTRICT AHMEDABAD, GUJARAT, INDIA (GPS Link:- )
SALARY PACKAGE:- RS.3.00 LACS TO RS.6.00 LACS ANNUAL CTC
Job Type: Full-time
Pay: ₹300, ₹600,000.00 per year
Work Location: In person
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