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Job as Assistant Manager- DQA in Mylan

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Clinical research courses

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 16,000, 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.

Post: Asst.Manager - DQA ( DoE Statistician )

Job Description:
A brief summary of the purpose this position must fulfill.
The incumbent will be responsible for providing statistical support to enable R&D scientists to optimize study designs and accelerate the availability of study results.

ESSENTIAL DUTIES AND RESPONSIBILITIES
Provide general strategic statistical consultancy to Formulation and Analytical Scientists.

Analyze the data using various statistical tools, interpretation of results.

Help navigate the regulatory expectations of USFDA. and respond to regulatory agency’s query on statistical evaluation.

Candidate Profile:
EDUCATION/EXPERIENCE
Masters or Bachelors of Pharmacy (preferred) or Masters or Bachelors of Science with Diploma in Statistics.
Industry Experience: 3 to 5 years work experience in the pharmaceutical industry or equivalent.

KNOWLEDGE
*    Proficiency in all aspects of MS office
*  Proficiency in Advance Excel: Conditional Formatting, Filtering, Sorting, Pivoting, Chart and Functions- IF, Macros, Look Ups,  Validation
*  Familiarity with Software based Design Of Experiments (DOE) applications that relies on multivariate modeling,.
*    Exposure to software tools like Design Expert, Minitab and JMP

SKILLS AND ABILITIES
Hands-on experience of DoE software(s) GMP, Design Experts, Minitab for pharmaceutical applications or other statistics tools.

Overview of statistical application for various development activities in R&D

Strong interpersonal skills – communication (oral and written) and presentation skills. Ability to work in multi-disciplinary teams and multi locations. Excellent problem-solving and decision-making skills.

Additional Information:
Experience: 3-5 years
Location:
Andhra Pradesh-Hyderabad
Industry Type: Pharma/Biotech/Clinical Research
End Date: 27th March, 2013

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