pharma quality assurance manager

2 days ago

Changodar Ahmedabad Gujarat, India Gujarat Pharmalab Pvt Ltd Full time ₹ 3,00,000 - ₹ 6,00,000 per year

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.

  1. WHO GMP NORMS

  2. PHARMA REGULATIONS

  3. PHARMA QUALITY MANAGEMENT SYSTEM

  4. PERFORMING VALIDATION, CALIBRATION & QUALIFICATIONS OF MACHINES, EQUIPMENTS, INSTRUMENTS & TOOLS

  5. PERFORMING ALL TYPES OF PROCESS VALIDATION

  6. PERFORMING AREA VALIDATION

  7. PERFORMING WATER VALIDATION

  8. PERFORMING CLEANING VALIDATION

  9. PERFORMING HOLD TIME STUDY

  10. PERFORMING ALL TYPES OF VALIDATIONS & CALIBRATIONS FALLING UNDER PHARMA MANUFACTURING PLANT

  11. DEVELOPING AND MAINTAINING DETAILED STANDARD OPERATING PROCEDURES, BATCH MANUFACTURING RECORD, BATCH PROCESSING RECORD & MASTER FORMULA RECORD

  12. DEVELOPING AND MAINTAINING SITE MASTER FILE

  13. DEVELOPING AND MAINTAINING ALL TYPES OF DETAILED DOCUMENTATIONS FALLING UNDER PHARMA QUALITY ASSURANCE, QUALITY CONTROL, PRODUCTION, ENGINEERING & STORE DEPARTMENTS

  14. PREPARING ERROR FREE CTD DOSSIER

  15. SEARCHING IN AND UNDERSTANDING PHARMACOPEIA

  16. DRAFTING OF APPLICATIONS OF PRODUCT LICENSES, CERTIFICATE OF PHARMACEUTICAL PRODUCTS AND FREE SALE CERTIFICATES ETC

  17. REVIEWING ARTWORK AS PER THE REGULATORY NORMS AND MAKING REQUIRED CORRECTIONS

  18. PERFORMING IN PROCESS QUALITY ASSURANCE ACTIVITIES

  19. FACED AND SUCCESSFULLY HANDLED COUNTRY SPECIFIC AUDITS

  20. IN DEPTH KNOWLEDGE OF PHARMASUITE ERP

  21. 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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