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kamal
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QA Officer
Officer /qa
OBJECTIVE:
Team-oriented personal commitment, human relations/integrity, giving and receiving constructive feedback, adaptability/personal style and diversity and communication. Works under general supervision. Maintain good housekeeping and a healthy, safe and environmentally acceptable working environment.
Sincerity, Honesty, Hard working, Punctuality, a disciplined approach and inclination towards team work . Appetite for learning and grasping more and more knowledge in every field.
COMPANY PROFILE : Current and previous
WORKING EXPERIENCE:
Presently working with Indoco Remedies Limited as QA officer from May 2008 to till date.
Worked with Panacea Biotec Ltd. as QA officer from Aug 2006 to April 2008.
Worked with ACME formulation Pvt. Ltd Nalagarh as QA Trainee officer from Sep.2005 to July 2006.
JOB SUMMARY : Worked in following Area as IPQA person
Tablet- Fabrication, Compression, Coating & Packing .
Capsule (Soft &Hard gelatin ) Mfg ,filling & Packing .
Liquid: Mfg ,Filling ,Sealing & Packing .
Ointment :Mfg, & Packing .
JOB RESPONSIBILITIES : ( This job responsibility for first company)
For 1st company
Line clearance in Tablet, Capsule, Ointment, and Liquid.
In process checks Tablet: - friability, weight variation, Disintegration testing, hardness of tablets, thickness of tablets, checking of RH& temperature of area.
In process in coating: - D.T, weight variation , % weight build up.
In process in packing: - Leak test, visual inspection of packing material Sealing testing , size of strip, RH &Temperature checking ,Retrieval and submission of ( Control , Finished and Stability ) Samples.
For 1I nd company
Line clearance , In process checks Tablet in various area .
Reviews batch record documentation to support the Quality Assurance release of product according to established procedures, cGMPs, and applicable regulations. Participate in the preparation and review of investigations, deviations, change control, consumer complaint investigations, and validation documents. Write and review standard operating procedures, annual product reviews, stability reports, Quality Standards, and other control documents.
Coordinate the Change Control meeting (generating agendas & minutes and processing of change controls).
Interact with regulated departments to improve current quality programs. Support cGMP and testing operations. Also having knowledge of process validation.
Utilize active thinking to generate creative solutions. Communicate process deviations and OOS and atypical results to management in a timely manner. Write / follow up QA/QC investigations. Support and fully contribute as a team member to achieving team objectives. Demonstrate business focus and results orientation, manage multiple priorities, follow schedules and meet deadlines.
Manage multiple products and priorities, follow schedules and meet deadlines. Document work accurately, precisely, completely and in an organized company . Audit / validate or check the work .
For Present company
Line clearance, In process checks Tablet, Liquid, Ointment & gel in various area.
Reviews batch record documentation to support the Quality Assurance release of product according to established procedures, cGMPs, and applicable regulations. Participate in the preparation and review of investigations, deviations, change control, consumer complaint investigations, and validation documents. Write and review standard operating procedures, annual product reviews, stability reports, Quality Standards, and other control documents.
Interact with regulated departments to improve current quality programs. Support cGMP and testing operations. Also having knowledge of process validation.
Utilize active thinking to generate creative solutions. Communicate process deviations and OOS and atypical results to management in a timely manner. Write / follow up QA/QC investigations. Support and fully contribute as a team member to achieving team objectives. Demonstrate business focus and results orientation, manage multiple priorities, follow schedules and meet deadlines.
Manage multiple products and priorities, follow schedules and meet deadlines. Document work accurately, precisely, completely and in an organized fashion. Audit / validate or check the work .
AUDIT FACED : NDA UGANDA , ANVISA Brazile
Educational Qualification :-
MSc.Biotechnology from Barkatullah University Bhopal. In the year 2005.
COMPUTER KNOWLEDGE
MS-Dos, Windows 98, MS-Word, MS Exel, SAP progammes.
PROJECT UNDERTAKEN:
Dissertation Work (M.Sc.): Micro propagation of MELIA AZADIRACHTA (an important medicinal tree) through tissue culture.
Project (B. Sc.)
To set up a tissue culture lab from horticulture university Bajaura (Mandi) in the year 2002 during final year of graduation.
Immunological programmed in year 2001 during second year of graduation.
Project on pasteurization in the year 2000 during first year of graduation.
Personal Information
Father Name : Sh. Prakash Chand
Date of Birth : 16th Sept. 1976
Marital Status : Single
Current Salary : 1.90 Lacs / annum
Date:
Place: (Kamal Kumar)
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