Manager - QA Validation - Vnagar - 3990
Manager - QA Validation - Vnagar - 3990
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Job Description
Validation/Qualification activities
Handling and leading QA validation activities (Which include Scheduled
Requalification New qualifications/validations due to Change control or
new projects New qualifications/validations due to introduction of new
products etc.) with taking care of 10-15 Nos. of team members.
Planning of all qualification related activities with concurrence of Sterile
manufacturing cross functional and PPMC department and release
area/equipment within stipulated time line.
Protocols review/Approval Guiding execution team and reports
review/Approval of following
Equipment qualification (Steam sterilizer vial washing machine
Lyophilizers Depyrogenation tunnel Vessels Filling machines (Vial
eye drop PFS cartridge) sealing machine Unidirectional air flow
units O-RABs units Terminal sterilizer Chambers Packing
equipments Material management area equipments Micro and QC
equipment Track and trace system BMS system etc.
Utilities qualification (HVAC Compressed air and nitrogen system
Pure steam generation and distribution system WFI/PW generation
system & distribution system etc.).
Air flow visualization study (Smoke study) of various equipment/HVAC system.
Protocol review/Approval and report review/Approval of Media fill.
SOP preparation/review related to QA validation department.
To review documents e.g. SOPs QA validation reports/Protocols QRM/FMEA URS DQ FAT reports Computer
system validation reports etc.
PROFESSIONAL SUMMARY OF
Prakash Ladola
M. Pharm (Pharmaceutics)
Name: Prakash Ladola
Present Address:
E 302 Vraj vihar near krish avenue
Vastral 382418
Ahmedabad
Permanent Address:
Bhimnath society Bhalgamda gate
Limbdi 363421
dist: Surendranagar
Mobile:
Email:
DOB: 26 May 1988
Marital status: Married
Membership:
Registered Pharmacist at Gujarat State
Pharmacy Council
Hobbies:
Reading Traveling Listening songs
and Cricket.
Languages known:
Gujarati Hindi and English
Computer skills:
MS office and SAP.
Total Professional Experience:
13 years in Quality Assurance
injectable
To Handle QMS related activity like change control/Deviation assessments CAPA implementation tracking and
closing of change control/deviation/CAPA related action items.
Protocol review/Approval and report review/approval of Process validation for Liquid (vial) Eye drop (plastic
bottle) suspension (vial) Microsphere terminal sterilization (vial) etc. products.
Handling of Cleaning validation activities which include protocol & matrix review/approval report review/approval
Assessment of existing cleaning validation status on introduction of new product or change in batch size or
equipment train etc.
Handling of activity and review of documents related Hold time study (CEHT DEHT and Product Hold time).
Halding of regulatory audits like USFDA Customer audit etc.
Facing and presenting various qualification/validation documents to internal and external regulatory
auditors.
Documents preparations/implementation of CAPA against audit observations.
Preparation and Implementation of contamination control strategy with reference to revised EU annexure I.
Required Experience:
Manager
Employment Type
Full Time
