Manager - QA Validation - Vnagar - 3990
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
equipment’s, 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: 8460215679,
8160337093
Email: Lprpharma@gmail.com
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.