Validation/Qualification activities

➢ Handling and leading QA validation activities (Which include Scheduled

Requalification, Current qualifications/validations due to Change control or new projects, Current 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: (phone hidden),

(phone hidden)

Email: [email protected]

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.

📌 Manager - QA Validation - Vnagar - 3990 (Ahmedabad)
🏢 Troikaa Group
📍 Ahmedabad