Magazine : Jatin Savani
Current
Pharma-QA
Education
M.Sc Industrial Chemistry
Industry
Pharma/Biotech/Clinical Research
About Jatin Savani
Over 6.5 Years Experience in various Quality Assurance functions of Pharmaceutical Manufacturing (Formulations & API)
Jatin Savani ’s experience
Product Manager/Project Manager/Manager/Supervisor/Team Leader
at
GlaxoSmithKline
, Mumbai, INDIA
September 2008 – Currently Working
Industry: Pharma/Biotech/Clinical Research
Functional area: Pharma / Biotech / Healthcare / Medical / R&D
•Raw Material Section: Planning & Release
•Handling of OOS
results •Operational Excellence •Quality Compliance
results •Operational Excellence •Quality Compliance
Sr.Officer-QA at Ranbaxy laboratories ltd , Indore, INDIA
January 2007 – September 2008
•Vendor qualification.
•Product Failure Investigation /
Handling of OOS results. •Handling of Market Complaint /
Product Complaint. •QA agreement for contract manufacturing
with regulatory aspects. •Change Control / Deviation
Management. •Gap Analysis in QA System and CAPA
monitoring. •Preparation of Annual Product Review.
(APR/PQR) •Assist Personal Training program. •Self
Inspection / Internal Audit •PQA in Tablet, Capsule, Dry
powder Injection, Oral Suspension mfg. area. (In absence of
dedicated person)
Handling of OOS results. •Handling of Market Complaint /
Product Complaint. •QA agreement for contract manufacturing
with regulatory aspects. •Change Control / Deviation
Management. •Gap Analysis in QA System and CAPA
monitoring. •Preparation of Annual Product Review.
(APR/PQR) •Assist Personal Training program. •Self
Inspection / Internal Audit •PQA in Tablet, Capsule, Dry
powder Injection, Oral Suspension mfg. area. (In absence of
dedicated person)
Asst. Officer - QA at Alembic Limited , Baroda, INDIA
March 2005 – January 2007
•Documentation and data control
-TTD, SOPs, BMR / BPR.
-QC
Specification and Method of Analysis. ( RM, PM, IP, FP,
GTP) -DMF, Patent Certificate. -Formats, Personnel Training
Record. -Validation and Qualification Protocols &
Reports. -Validation Master Plan. -Process Flow
Diagrams. -Instrument Calibration Records. -Site Master File,
Quality Manual •Internal Audit and compliance activity,
CAPA •TTD review •Preparation and handling of Regulatory
Audit & Customer Audit •Support Validation
activity. •BMR / BPR review and Batch release
activity. •Management of sampling activity including
Validation & Stability samples. •Trend Analysis & APQR
•Preparation and
control of SOPs. •Handling of Market / Customer
Complaint. •Change Control & Deviation Control. •Review of
Supporting documents for regulatory submission. •Communication
with RA, Marketing & Stability.
Specification and Method of Analysis. ( RM, PM, IP, FP,
GTP) -DMF, Patent Certificate. -Formats, Personnel Training
Record. -Validation and Qualification Protocols &
Reports. -Validation Master Plan. -Process Flow
Diagrams. -Instrument Calibration Records. -Site Master File,
Quality Manual •Internal Audit and compliance activity,
CAPA •TTD review •Preparation and handling of Regulatory
Audit & Customer Audit •Support Validation
activity. •BMR / BPR review and Batch release
activity. •Management of sampling activity including
Validation & Stability samples. •Trend Analysis & APQR
•Preparation and
control of SOPs. •Handling of Market / Customer
Complaint. •Change Control & Deviation Control. •Review of
Supporting documents for regulatory submission. •Communication
with RA, Marketing & Stability.
Chemist-QA at J.B.Chemicals & Pharmaceuticals Ltd. , Ankleshwar, INDIA
September 2004 – February 2005
•Sampling of Tablet, Capsule, Oral Liquid, SVP & LVP, &
Ointment. •Area clearance and Line clearance. •In-Process
testing of Tablet & Capsule. •Management of Stability and
Validation samples. •Implementation G.M.P. practice on
shop-floor. •Shop floor monitoring. •BMR
review. •Internal Audit and compliance activity. •Trend
Analysis •Issuance of Raw Materials to Production. •Product
Failure Investigation
Ointment. •Area clearance and Line clearance. •In-Process
testing of Tablet & Capsule. •Management of Stability and
Validation samples. •Implementation G.M.P. practice on
shop-floor. •Shop floor monitoring. •BMR
review. •Internal Audit and compliance activity. •Trend
Analysis •Issuance of Raw Materials to Production. •Product
Failure Investigation
Jatin Savani ’s education
M.Sc [Industrial Chemistry],
Bhavnagar University [July,2004]
, Bhavnagar, INDIA
B.Sc [Industrial Chemistry],
Bhavnagar University [June,2002] , Bhavnagar, INDIA
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