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: (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 current 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 (India)
🏢 Troikaa Group
📍 India