Tilak Dave
Dy.manager-Quality Control
Vadodara,Gujarat
Summary
Diligent and ambitious deputy manager with several years of industry experience. Possesses exceptional leadership and conflict resolution skills. Committed to ensuring that all associates deliver the utmost level of customer service.
Overview
15
15
years of professional experience
Work History
Dy.Manager - Quality Control
Alembic Pharmaceutical Ltd
Vadodara
09.2018 - Current
- Handled GLP section, Training Section and Analyst Qualification, Finish Product release Individually, Having team of 10 analyst
- Plan and release finish products in timely manner
- Managing all calibration & Qualification activities in QC laboratory including validation strategy and review protocols and reports
- CSV (Computerized software validation) of various software Execution Plan and Execute Laboratory modification required by the management
- Look after the activity for SOP, IOCP Preparation and Corporate Document Implementation at site wise
- Ensuring appropriate investigation of discrepancies, errors, complaints, failures, OOS, OOC, Lab Incident or adverse events recurring documented review and action
- Maintaining and improving departmental operational performance to meet the requirements of regulatory authorities, company standard operating procedures and external and internal customers with respect to quality, service, lead time and cost
- Ensure all necessary testing carried out and evaluate associated record
- Plan and Execution of External vendor calibration and various Contract AMC and CMC agreement
- To participate in self-inspection (Internal GMP Audits) as an internal auditor
- To ensure the required initial and continuing training program for Quality control personnel is carried out and adapted according to Training requirement.
- Coordinated with other departments to ensure smooth functioning of activities.
- Monitored daily operations and ensured compliance with company policies and regulations.
- Provided necessary technical assistance and advice to subordinates when needed.
- Developed and implemented new procedures to improve efficiency of the organization.
Executive
LUPIN LIMITED
Ankleshwar
04.2015 - 09.2018
- I have worked with Lupin Limited, Ankleshwar as a Executive and working in GLP , Finish ,Working standard Section
- Plan and Release Finish Product and Raw material timely
- Handled GLP department individually with timely review all the documents
- Looking activities like Calibration, Standard Management, Trouble shooting of Instruments, Procure New Instruments, Software updating, Software validation Assessment, Qualification and Approval of new and existing equipment and instruments within QC laboratory
- Ensuring Quality department meets on budget, cost and efficiency targets in line with business objectives
- Preparing and justifying the Quality control section budget
- Plan and call to outside engineer for preventive maintenance, system breakdown
- Looking activity like AMC and CMC contract for Instruments with external agency, Installation of new instrument or up gradation of software
- Handling of change control and actively investigate OOS, OOT, OOC
- Successfully completed and applying project of working standard management through SAP
- Performing CSV (computer software validation) for standalone system and server-based system.
GLP Study Personnel
CHEMINOVA (I) LTD
Panoli
10.2014 - 04.2015
- In Cheminova get exposure for new starting GLP lab
- Worked with CHEMINOVA (I) LTD as a GLP study personnel for Technical division
- Coordinated with team members to establish GLP department and its routine activity
- Perform study as per study plan and dates and doing calibration of instruments like HPLC, LC-MS,GC,GC-MS Autotitrator,FTIR,KF
- Perform Method Validation and documentation as per GLP requirement.
Officer grade-II
Sun Pharmaceutical Ltd
Halol
11.2012 - 10.2014
- Worked with Sun Pharma as a Officer grade-II in RAW material section
- Performed Raw material analysis on HPLC, UPLC
- (Functional area in HPLC Dept.) Assist QC head in various documentation and various audits
- Performed individual analysis of raw material and Calibration of HPLC Performed joint analysis with different sun pharma Site for any customer complain
- Documentation:- Prepare OOS and change control documents
Jr.Executive
Fermenta Biotech
Dahej
08.2011 - 10.2012
- Worked with Fermenta biotech as Jr.Executive at the time of company establish
- As in fermenta biotech I got exposure for starting new facility laboratory (Green field Project) and Qualification of Instruments
- Performed wet analysis and analysis on GC and HPLC
- Assist QC head in various documentation
- Performed individual analysis of raw material, wet analysis
- Calibration and Analysis on all instruments like GC, HPLC, Auto titrator, polarimeter ,UV-Spectrophotometer,Melting Apparatus
- Performed Hold Time study and validation
- Performed Investigate for OOS,OOC Documentation:- Prepare COA of RM, Intermediate and Finished API
- Prepare OOS and change control documents.
QC Chemist
Zydus Cadila Healthcare
Ankleshwar
06.2010 - 08.2011
- Performing wet analysis of products and analysis on GC. (Functional area in GC Dept.)
- Calibration of Gas-chromatograph.
- Checking the chromatograms of GC.
- Assisting Q.C. Head in various documentation.
- Handled independently all GC instrument with Liquid injection (Auto sampler), Head- space for
- Performing Residual Solvent of API and Intermediate.
QC Chemist
Ion Exchange Ltd
Ankleshwar
10.2009 - 06.2010
- Started carrier with Ion exchange India limited, Ankleshwar as contract chwemist here perform Chemical analysis.
Education
Master of Science - Industrial Chemistry
ISTAR
Vallabh Vidyanagar, GJ06-2009
Bachelor of Science - Industrial Chemistry
N.V Patel College of Science
Vallabh Vidyanagar, GJ06-2007
G.S.H.E. Board -
R.S Dalal High School
Bharuch, GJ06-2004
G.S.E. Board -
Rukmanidevi Rungta Vidyalaya
Bharuch, GJ06-2002
Skills
- Process and procedure development
- Cost analysis and savings
- Purchasing and planning
- Quick decision-making abilities
- Task Delegation
- Performance Improvements
Affiliations
· Taken Training of Internal auditor course by bureau veritas.
· Take part in IPC (Indian pharmacopeias Commission) Training at Gandhinagar.
· Training taken of ICP-MS at Delhi.
· Awarded as best Team leader in project at Lupin Ankleshwar site.
· Appointed as “BUDDY” by HR department of Lupin Ankleshwar.
· Participate in Chromeleon software training in Mumbai (HO site) of Lupin.
· Awarded as star performer ofLupin.
Languages
Gujarati
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Computer Literacy and Software knowledge
· MS Office (Word, Excel, Power Point)
· LIMS-caliber and LIMS-Labware
· SAP
· Documentum
· QAMS
· LMS (Learning Management System)
· Mini Tab (Satirical Software for OOT)
· Chromeleon,m-Power,LC solution,EZ-chrome
· DCS (Document control system)
Timeline
Dy.Manager - Quality Control
Alembic Pharmaceutical Ltd
09.2018 - Current
Executive
LUPIN LIMITED
04.2015 - 09.2018
GLP Study Personnel
CHEMINOVA (I) LTD
10.2014 - 04.2015
Officer grade-II
Sun Pharmaceutical Ltd
11.2012 - 10.2014
Jr.Executive
Fermenta Biotech
08.2011 - 10.2012
QC Chemist
Zydus Cadila Healthcare
06.2010 - 08.2011
QC Chemist
Ion Exchange Ltd
10.2009 - 06.2010
Master of Science - Industrial Chemistry
ISTAR
Bachelor of Science - Industrial Chemistry
N.V Patel College of Science
G.S.H.E. Board -
R.S Dalal High School
G.S.E. Board -
Rukmanidevi Rungta Vidyalaya
Similar Profiles
Vikas JhaVikas Jha
Area Sales Manager at Alembic Pharmaceutical Pvt LtdArea Sales Manager at Alembic Pharmaceutical Pvt Ltd
Purna GadwaniPurna Gadwani
Deputy Manager at Quality Assurance, Injectable Division, Alembic Pharmaceutical Ltd.Deputy Manager at Quality Assurance, Injectable Division, Alembic Pharmaceutical Ltd.
Sandesh KGSandesh KG
Research Scientist at Alembic Pharmaceutical LtdResearch Scientist at Alembic Pharmaceutical Ltd