You are hereVacancy for the post of QA auditor at Apotex Research
Vacancy for the post of QA auditor at Apotex Research
Apotex Research Pvt. Ltd. is a wholly owned subsidiary of Apotex Inc. Canada which is a number one generic pharma co. in Canada. The position is for Bangalore location which has an R&D Centre, Manufacturing and a Bioequivalence Centre.
Post: QA- Reviewer, Auditor
Job Description:
-To be responsible for all activities in the Quality Assurance, including cGMP/cGLP, documentation and implementation of departmental quality systems.
-To ensure the smooth general day-to-day functioning of the Quality Assurance.
-Documentation control: ensuring archival / retrieval and updation of documentation as per regulatory compliance
-To review various documents like Standard operating procedures, Formats, Validation/stability protocols, Validation reports, Specifications, Method of analysis, Analytical reports etc. for the analytical support to SVMP-QC, Analytical Laboratory and Product Evaluation and Analytical Support Laboratory.
-Review the analytical reports/Validation reports to assure that such report accurately describes the methods and SOP’s and that the reported results accurately reflect the raw data of laboratory.
-Provide technical inputs for HPLC/GC/UV etc., trouble shooting whenever required.
-Review of change controls, deviations and quality incident reports
-Review of qualification/validation of Laboratory instruments.
-Co-ordination Out of specification (OOS) investigation and reporting.
-Preparation for regulatory audits and making the compliance for the same.
-Responsible for implementation of SAP/LIMS and harmonization of the process and procedures with Apotex Inc.
-Adherence to the other Responsibilities as assigned by Group Leader – Analytical and Quality Assurance.
-Perform additional task as assigned by Manager-QA.
Candidate Profile:
Must be a Post Graduate with M.Sc or M.Pharma background. Hands on experience into formualtions sIide of Quality Assurance functioning.
Other Information:
Experience: 2-5 year
Location: Bengaluru/Bangalore
Education: M.Pharm, M.Sc
Industry Type: Pharma/biotech/Clinical research
Functional Area: Quality Assurance
Contact: Mr Vishnu Reddy
Address: Apotex Research Pvt Ltd
Site No.1, Bommasandra Indl Area,
4th Phase Jigani
Link Road-560001
Telephone: 080-22151439
Apply/Send resume at, careers@apotex.co.in or vreddy4@apotex.co.in
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Ketan N. Thube.
e-mail : thube_ketan@rediffmail.com
Contact No – 09921270050
09028994359
RESUME (H) 02412324549
CAREER OBJECTIVE:
To seek a challenging position that offers opportunity to explore my Qualification, Experience and Skills in the area of Formulation, Research and Development , Quality Assurance, Regulatory affairs. in such Organizations that provides a work environment that Foster teamwork and allows independent responsibilities.
EDUCATION QUALIFICATIONS:
Qualification |
Institute |
University / Board |
Year of Passing |
Percentage |
M. Pharm 2nd(Pharmaceutics) |
LuqmanCollege of Pharmacy, Gulbarga |
RajivGandhi University Of Health Science, Bangalore. |
2009-10 |
Results awaited |
M. Pharm 1st(Pharmaceutics) |
LuqmanCollege of Pharmacy, Gulbarga |
RajivGandhi University Of Health Science, Bangalore. |
2008-09 |
72.00 |
Final yearB. Pharm |
P.D.V.V.P.F’s College of Pharmacy,Ahmednagar. |
PuneUniversity, Pune |
2007-08 |
59.71 |
T.Y.B. Pharm |
P.D.V.V.P.F’s College of Pharmacy,Ahmednagar. |
PuneUniversity, Pune |
2006-07 |
56.25 |
S.Y.B. Pharm |
P.D.V.V.P.F’s College of Pharmacy,Ahmednagar. |
PuneUniversity, Pune |
2005-06 |
59.75 |
F.Y.B. Pharm |
P.D.V.V.P.F’s College of Pharmacy,Ahmednagar. |
PuneUniversity, Pune |
2004-05 |
59.25 |
PROJECTS UNDERTAKEN:
M. Pharm Research Project: “Formulation and evaluation of mouth dissolving tablets of metoprolol tartrate.”
Other than research Project: “Formulation and evaluation mouth dissolving tablets of metoprolol tartrate by using natural superdisintegrant”.
Area of Intertest:
- Research and Development, Quality Assurance, Regulatory affairs.
Computer Skills:
Operating System : Windows XP/Vista
Software : Ms-Office
Networking : Internet.
Industrial EXPERIENCE:
- Four months industrialexperience at Glenmark Pharma. in Quality Assurance, Ambad, Nasik.
Participation and attendance in conference and seminars:
- Attended an Orientation course on research methods and bio-statics, by RGUHS Nov. 2008.
- Attended and registered member of APTI 2009, Jodhpur, Rajasthan.
- Attended and registered member of IPC 2009, Ahmadabad, Gujarat.
PRESENTATIONS:
- Ram dolas,Ketan Thube,Shashikant Wagh. “Roll of DOTS treatment in R.N.T.C.P. Program (Evaluation of curing rate of T.B. in DOTS treatment)’’ In IPC - 2006, Mumbai.
- N. G. Raghavendra Rao, Ketan Thube,Ravi kumar.“Comparative study on effect of different techniques used in the development of chlorthalidone fast dissolving tablets” In APTICON-2009, Jodhpur, Rajasthan.
- N. G. Raghavendra Rao, Ketan Thube, Suryakar V.B, S.S Bushetti. “Functionality comparison of 4 different types of superdisintegrants in designing of Metoprolol tartrate fast dissolving tablets.” Poster presented at 61 st IPC held at Ahmedabad, Dec. 2009.
- N. G. Raghavendra Rao, Thube Ketan, Pentewar Ram, Suryakar Vijay. “Formulation and evaluation of mouth dissolving tablets of metoprolol tartrate by sublimation method”. Poster presented at IPA Convention 2010 at Chennai. March.2010.
Publications:
- N. G. Raghavendra Rao,Ketan Thube,d. k. suresh. Formulation and Evaluation of Mouth Dissolving Tablets of Metoprolol Tartrate by Sublimation Method. International Journal of Pharma and Bio Sciences (IJPBS). (In press)(Accepted and published in the month of March-May 2010).
- N. G. Raghavendra Rao, Ketan Thube,v. b. Suryakar. Comparison of Different Superdisintegrants in Designing of Fast Dissolving Tablets of Metoprolol Tartrate. International Journal of Pharmaceutical Sciences and Research (IJPSR) March, 2010, Vol 1, Issue 4 (56-66).
- N. G. Raghavendra Rao, Ketan Thube,v. b. Suryakar.“Formulation and evaluation mouth dissolving tablets of metoprolol tartrate by using natural superdisintegrant” International Journal of Pharmaceutical and clinical research. January-March, 2010, Vol 2,Issue I (40-45).
- N. G. Raghavendra Rao, Ketan Thube,v. b. Suryakar. “Development of mucoadhesive films for buccal administration of montelukast” International journal of pharmacy and technology. March 2010/Vol 2/Issue 1/Page 1-15.
PERSONAL DETAILS:
Date of Birth : November 07th, 1985
Age : 24Yrs
Mobile No. : 09921270050, (0241)2324549
Permanent Address : ‘OMKAR’Plot no.5, H.G.S. Housing society, Adarsh nagar, Nagar kalyan road, Ahmednagar 414001, Maharashtra, India.
Gender : Male
Marital Status : Single
Languages Known : English, Hindi and Marathi.
Reference:
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1)Dr. S.Z. Chemte, Professor and HOD Pharmaceutics, P.D.V.V.P.F’s College of Pharmacy, Vilad Ghat, Ahmednagar – 414001, Maharashtra, India. 09822210375.
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Professor and HOD Pharmaceutics, LuqmanCollegeof Pharmacy, P & T colony, Gulbarga, Karnataka, India e-mail: ngraghu@rediffmail.com 09448570193
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DECLARATION:
I here by solemnly, do affirm that the particulars furnished above are true to the best of my knowledge.
Place:Ahmednagar.
Date: KETAN N. THUBE.
PLEASE NOTIFY THAT THIS JOB IS EXPIRED.
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