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: Team Member - Quality Assurance-16000533
Job Description:
The Team Member - Quality Assurance will have the following key responsibilities
1) Prepare controlled documents; Conduct distribution, retrieval, archival and destruction of controlled documents; Prepare new documents as per cGMP requirement, as and when required.
2) 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; Conclusion of re-training requirements
3) Track and highlight deviations in manufacturing operations to the supervisor; Provide line clearances after satisafactory review; FDF: Perform in-process sampling as per production schedule
4) 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
5) Prepare and update the vendor list as per the schedule; Initiate the vendor evaluation documents; Maintenance of master data SAP related to vendor
6) Prepare the APQR report; Summarize the data collected in APQR preperation; Assist supervisor in preparing recommendations based on APQR evaluation
Candidate Profile
Graduate degree in Pharmacy / Chemistry
Minimum 1 year of experience in pharma industry
Application knowledge of Regulatory requirements
Knowledge of Quality Management System, GMP Requirements
Knowledge and experience of regulatory audits(USFDA, EUGMP etc)
Proficiency in speaking, comprehending, reading and writing English is required / preferred.
Additional Information:
Experience: 1 year
Qualification: B.Pharm
Location: Andhra Pradesh-Hyderabad
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 25th June, 2016
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