Manager Quality
Resume:
ARUNI SHARMA
Village - Handal P.O Pirsaluhi Tehsil Rakkar
Distt.- Kangra (HP) – 177034
E-mail: ************@*****.**.**
Mobile No: 088********,095********
Objective: Seeking Challenging assignment and responsible position in Quality Control of Pharmaceutical at next position by self-initiation.
Synopsis : A pharma professional having approximately 12.5 years of experience in pharmaceutical industry with good intellectual and communication oration in Quality control Department.
Academic Qualification
M.Sc Chemistry from MK University, Madurai with 2nd class.
Present Tenure: Working with Scott-Edil Pharmacia Ltd. Baddi as a Manager Quality Control from Dec.2017 to till date.
Organization contour:
Scott-Edil Pharmacia Ltd. Baddi
From Dec. 2017 to till date
Manager QC
Emcure pharmaceutical Ltd. Jammu
From May. 2016 to Dec. 2017
Assistant Manager QC
Alembic pharmaceutical Ltd. Baddi
From Nov. 2011 to May 2016
Sr. Executive QC
Macleod pharmaceuticals Ltd Baddi (MHRA, USFDA plant).
From Dec. 2008 to Nov. 2011
Sr. Officer QC
Hetero Drugs Ltd. Baddi
From May. 2007 to Dec. 2008
Chemist QC
Key responsibilities:
Current Job profile in Scott-Edil Pharmacia
Presently working as a Manager QC to Ensuring and controlling all the activities performed in the quality control laboratory in compliance to the cGMP/cGLP as per current regulatory requirements.
To ensure planning for sampling, analysis, online documentation, review of results and release of Raw Material, Packaging Material as per current Good Laboratory Practices.
To ensure planning for analysis, online documentation, review of results and result recording of Finished Product and In process / bulk sample as per current Good Laboratory Practices.
To ensure planning, analysis, online documentation, preparation of reports of Stability Study Sample as per ICH Guidelines.
To ensure that all Finished Product, Raw material, Stability Study samples, Packaging material are analyzed w.r.t. concerned Specification and MOA’s. (Pharmacopoeia and / or In-house)
To ensure submission of stability data to QA / RA for registration of drug products to different regulatory bodies.
To check all the SOPs, MOA’s, Specifications, GTP and Protocols of Quality Control Department.
Responsible for Qualification of instrument and equipment of Quality Control Department.
To ensure Internal and External Calibration / Validation, Temperature Mapping and AMC of Instrument and Equipment of Quality Control Department.
Ensure that all analysts are trained and qualified in required analytical test methods / techniques.
Ensure that all analysts understand and follow current good laboratory practices.
Ensure that the team leader is updated about the activities and status on a daily basis and verify daily work allotment on weekly basis.
Ensure that all OOS and Laboratory Incidents are properly closed.
To discuss and conclude all product related issues and method related issues with the respective cross functional teams.
Ensure that adequate laboratory space, equipment, glassware documents and other requirements are provided timely to the analysts.
To maintain good housekeeping and maintain the lab in a presentable way.
Ensure that all the laboratory testing methods meet the current requirements.
To arrange internal and external training for QC persons to improve knowledge and work efficiency.
Responsible for Laboratory Quality management system and internal /external Audit as per different regulatory bodies.
Previous Organization Job Profile
Planning for method validation/verification and process validation in quality control.
Execution, preparation and review the method validation and process validation protocol and reports.
To perform on the Cleaning method validation.
Review of all test data sheets of finish goods, validation and stability studies.
Preparation and review of Specification’s and STP’s.
Investigation and filing of incidences and OOT.
Handling of OOS, OOT and Incidence during routine analysis.
Troubleshooting of Lab instruments during routine analysis.
Making of protocols, Sop’s And STP as per the guidelines and pharmacopeia.
To ensure correct use of equipment; training and building a team of analyst & technicians with high competency; maintenance of lab supplies.
Establish quality standard, supervise quality control team
Defines lab procedures; maintain proper documentation.
Carry out over all quality review.
Carry out investigations on quality issues and conduct troubleshooting.
Handling of incidents, change control, deviation and QMS in quality control labs.
To maintain GLP and ensure the implementation of cGMP norms within the facility in laboratory.
Review the GLP work data sheet and records
To provide training on Sop’s to analysts in lab.
Review of test reports, summary reports and certificate of analysis for accuracy and completeness as received from outside labs.
Ensure qualification of new equipment and calibration as per schedule.
Conduct/oversee backup of all computer related software used in QC lab.
To facilitate GMP/GLP compliance and monitor effectiveness of personal hygiene.
Overall review of GLP activities.
Review the calibration of instrument as per annual schedule.
Planning for Finish product, process validation sample and method validation analysis.
Responsible for preparation and updating of Finish product SOPs and STPs.
Responsible for running Stability section safely, efficiently and independenty
Handling of stability samples as per local and export market.
Responsible for charging of stability samples and updating of location chart of chambers.
Responsible for preparation and updating of Stability Protocol.
Responsible for withdrawing and
Responsible for preventive maintenance, calibration and revalidation of stability chambers.
Preparation of master schedule for new charged products.
Preparation of monthly scheduler.
Responsible for alarm annunciation system.
Preparation of summary reports
Review of stability studies reports.
Monitoring of temperature and humidity records of stability chambers.
Preparation of monthly stability scheduler for microbiology section.
To identify, arrange and conduct training as per cGMP requirements.
Trouble shooting during routine analysis to achieve quality and output.
Preparation of Stability protocols and performing analysis as per guidelines.
Instrumental relam:
(1) HPLC
Agilent with RI, PDA & UV detector.(On line Chromleon Software)
Shimadzu LC Solution ( LC2010 AHT,LC2010 CHT),Lab solution
Dionex (Ultimate 3000)
(2) IR:
Shimadzu (Shimadzu 8400s)
Perkin Elmer (FTIR)
(3) UV Spectrophotometer
Shimadzu (model 1700)
Perkin Elmer
(4) Dissolution, Disintegration,GC & Other QC instrument.
Audit Faced
USFDA, MHRA, MCC, WHO, ANVISA
Computer Skills:-Good knowledge of computer (MS-Office, Power point, MS word, excel,).
Good knowledge of pharmaceutical software LIMS (laboratory information management system), ERP and SAP (system application processor).
Personal Profile:
Name
:
Aruni Sharma
Father’s Name
:
Om parkash
Permanent Address
:
Village - Handal P.O Pirsaluhi Tehsil Rakkar
Distt.- Kangra
(HP) – 177034
Date of birth
:
20-05-1985
Marital Status
:
Married
Languages known
:
Hindi and English
Current CTC
:
8.90 lac./annum
Expected CTC
:
Negotiable
Declaration: The above all information is true to the best of my knowledge & belief.
Date:
Place: Aruni Sharma
(************@*****.**.**) 088********, 095********
Contact this candidate