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Quality Assurance Engineer Resume Sample, Experience : 5 years

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Name of the Candidate:[Private]
Name of the Post Applied:Quality Assurance Engineer
Job related skills / software:Handling of Quality System documents like change control, deviations, OOS documents, Root cause investigations and OOT study in stability studies.
Category:Medical
Sub Category:Quality Assurance Executive
Years of Experience:5 years
State:Telangana
Gender:Male
Salary Expected per Month(Rs):50,000 to 60,000
Highest Qualification attained:M.Pharm. : Master of Pharmacy
Major / Specialization:Pharmaceutics
Email Id:[Private]
 
Are you looking for job now?:Yes
Can the recruiter contact you?:Yes
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Resume Format / CV Sample Template / Example / Model :

    

Curriculum Vitae:
P. Srinivas
M.Pharmacy, Pharmaceutics
Email ID : Srinu.vas89 AT gmail.com

An Overview :
** A result oriented pharma professional with experience of working in Quality Control and Quality Assurance.
** Currently employed with - Dr. Reddy's Laboratories as Team Member (Quality Assurance).
** Knowledge of regulatory guidelines and experience in good documentation practices.
** Ability to support andsustain a positive work environment that fosters team performance.

Career objective :
To work in a challenging environment where I can utilize my Industrial experience to the best of my abilities and contribute for the growth and development of an organization.

Current Work Experience :
Current Position :- Asst. Manager -Quality Assurance from November-2018 to till date.
Key Role : Quality Management Systems (QMS) & AnalyticalQuality Assurance (Reviewer)

Handling of Deviations/OOS/OOT/CC in Track Wise :
Handling of Quality System documents like change control, deviations, OOS documents, Root cause investigations and OOT study in stability studies.

Stability study management :
** Planning stability studies for validation batches.
** Identifying & designing stability requirement matrix as per guidelines & regulatory requirements.
** Identifying additional stability study requirements like pack profile change, batch size change, change in API source, reprocessing, reworking etc.
** Identifying deviations to approved stability schedules
** Preparation, review and execution of stability protocols.

AnalyticalQuality Assurance (Reviewer)  :
** Review of Analytical reports of in-process and finished products related to solid oral dosage forms (ODF)
** Review of analytical records related to stability studies
** Review of electronic data in 21 CFR compliant QC equipment’s like UV, IR, HPLC
** Review of validation related analytical reports : Cleaning validation & Process validation
** Handling and review of analytical reports through LIMS

Handling of SAP :
Material management through SAP, posting usage decision after review of analytical reports. Handling of online rejection of material through SAP.

Auditing :
** Conducting regular rounds to QC lab. Identifying deviations from written procedures.
** Special skills of identifying QC related data integrity related issues, if any.
** To participate in internal audits.

Training :
** Conducting cGMP training session for cross-functional teams & GLP training to QC analysts.
** Online training sessions through Learning Management System (LMS).
** To participate in revision and review of corporate procedures.

Management skills :
** Conducting technical rounds of interviews and providing feedback to management.
** Participate in meetings related to technology/product transfer and identify the quality impacting parameters
** To participate in monthly Quality System Review meetings and communicating MoM to respective stakeholders.

Previous Work Experience :
Previous Position :- Executive-Quality Control (Analyst) from November 2014 to November 2015.
Previous Employer : - Adcock Ingram Ltd., Bangalore, Karnataka
Previous Position :- Executive-Quality AssurancefromNovember 2015 toJune 2018.
Previous Employer :- Strides Shasun Limited.


Bangalore, Karnataka

Software’s Handled  :
Track wise : For Handling of Change Controls, Deviation, CAPA, OOS and OOTSAP
LIMS(Laboratory Instrument and Management System) : I.e. Caliber & Labware V.6.0 & V.7.0.2. Talent-Hub & Nichelon( Training Management )

Audits Participated :
Successfully participated with USFDA,MHRA,TGA,WHO,CDSCO and internal audits etc.,

Strengths :
** Ability to initiate assigned tasks, work independently and to manage multiple projects.
** Highly adjustable to any environment, very supportive in group.
** Highly inquisitive, creative and resourceful and willingness to be a continuous learner
** Pre-planned goals and precise in doing work, Hard-working, detailed oriented and able to do multi task.
** Effective organization, communication and team orientation skills.

Educational Testimony :
** M. Pharmacy Pharmaceutics (2012-2014) in Slc’s College of Pharmacy affiliated to JNTU University.
** B. Pharmacy (2008-2012) in MRR College of Pharmacy, placed in First division, affiliated to JNTU University.
** Intermediate (2005-2007)- in Vikas Jr. College, Guntur, Board of Intermediate education.
** SSC (2005)- in Nalanda Public School, placed in First division from SSC Board

Presentation and conferences attended :
** Presented paper on Nano Technology at National Level Technical symposium in Bharat College, Hyderabad
** Participated in the Industrial work at Natco Pharma Ltd, Nagarjuna Sagar.
** Took part in service campaigns.

Academic Project :
** Computational studies on Development of sustained release matrix tablets of Zidovudine by natural gums.
** Zidovudine is anti-viral drug
** Using bioinfo softwares to finding the particular gene responsible for disease.

Personal Details :
Name : Srinivas Puchakatla
Date of birth : June 04, 1989
Marital Status : Unmarried
Languages known : English, Telugu and Hindi
Nationality : Indian

Declaration :
I hereby declare that, all the above information is true and correct to the best of my knowledge and Belief.

Place :  Bangalore
Date :

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