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Quality Assurance Chemist Required in Mylan

By: Pharma Jobs | Views: 3436 | Date: 17-Oct-2013

Mylan Laboratories Limitedwww.mylanlabs.inMylan is one of the world�s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry�s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 18,000, Mylan has attained leading positions in key international markets through its wide array of dosage

Senior Chemist - Quality Assurance - Unit-3

by Mylan Laboratories Limited in Hyderabad / Secunderabad

Experience: 4 to 7 yrs. Posted on: 03 Oct


Mylan Laboratories Limited, India

Job Description

Prepare, distribute, retrieve, archive and destruct controlled documents. Support DMF/ANDA filing and regulatory queries. Prepare new documents as per cGMP requirement, as and when required.
Prepare employee training curriculum, annual schedules. Coordinate with internal trainers and execute the training as per schedule.
Maintain, check and update the training records. Assess the training evaluation questionnaires. Conclude re-training requirements.
Track and highlight deviations in manufacturing operations to the supervisor and provide line clearances after satisfactory review
FDF: Perform in-process sampling as per production schedule
Initiate the change control with necessary document support. Execute the approved changes as per the action plan.
Prepare the validation protocols and reports. Verify documents with current equipment capability. Execute the validation/qualification processes at each stage of manufacturing
Prepare and update the vendor list as per the schedule. Initiate the vendor evaluation documents. Maintain master data SAP related to vendor
Prepare the APQR report; summarize the data collected in APQR preparation; assist supervisor in preparing recommendations based on APQR evaluation
Salary:

Not Disclosed by Recruiter

Industry:

Pharma / Biotech / Clinical Research

Functional Area:

Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:

R&D

Role:

Pharmacist/Chemist/Bio Chemist

Keyskills:

Senior ChemistQuality AssuranceRegulatoryQuality Management SystemPrepare validation protocols

Desired Candidate Profile

Education:

UG - B.Pharma - Pharmacy, B.Sc - Chemistry
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate - Doctorate Not Required

Graduate degree in Pharmacy/Chemistry
Minimum 4 years of experience in pharma industry
Application knowledge of Regulatory requirements
Knowledge of Quality Management System
Knowledge of GMP Requirements
Knowledge and experience of regulatory audits (USFDA, EUGMP etc)

Company Profile

Mylan Laboratories Limited
www.mylanlabs.in
Mylan is one of the world�s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry�s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 18,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service. The company ranks among the top five generics companies in several markets around the world and is the largest U.S.-based generics manufacturer in the world. Through its India-based subsidiary Mylan Laboratories Limited, Mylan has direct access to one of the world�s largest active pharmaceutical ingredient (API) manufacturers. This relationship makes Mylan one of only two global generics companies with a comprehensive, vertically integrated supply chain. Mylan Laboratories Limited also is one of the world�s largest producers of API used to make generic antiretroviral (ARV) therapies for the treatment of HIV/AIDS. Additionally, Mylan operates a fully integrated specialty pharmaceutical business, Mylan Specialty (f/k/a Dey), which produces innovative medicinal therapies, including EpiPen® Auto-Injector.

Contact Details
Recruiter Name:

HR

Contact Company:

Mylan Laboratories Limited

Reference Id:

13002013



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Comments
N.S.SUDARSHANA KRISHNA  |  30-Oct-2013 12:21:14 IST
I am looking for immediate job anywhere in India, This particular job suits me for my experience , and qualification.Kindly considre my resume for the same and oblige me.
Thanking you,
Regards
N.S.Sudarshana Krishna
sravanitha  |  04-Dec-2013 12:57:42 IST
i haven interest to join
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