Trainee @ Mylan In hyderabad
Company: Mylan Laboratories Limited.
Company Website: www.mylan.com
Company profile: Our history, our mission and our values tell the story of who we are as a company. We began as a pharmaceutical distributor, providing products to customers in smaller communities. Today we’re one of the world’s leading generics and specialty pharmaceutical companies, with sales in approximately 140 countries and territories. And our dedication to providing access to medicine continues to grow after more than 50 years.
Qualification: Any Graduate
Experience: 1 Years
Location: Hyderabad
Industry: IT/Software
Key Skills: USFDA, EUGMP
Job Description:
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.
Qualifications:
1. Graduate degree in Pharmacy / Chemistry.
2. Minimum 1 year of experience in pharma industry.
3. Application knowledge of Regulatory requirements.
4. Knowledge of Quality Management System, GMP Requirements.
5. Knowledge and experience of regulatory audits(USFDA, EUGMP etc).
Click Here To Apply Job
Company Website: www.mylan.com
Company profile: Our history, our mission and our values tell the story of who we are as a company. We began as a pharmaceutical distributor, providing products to customers in smaller communities. Today we’re one of the world’s leading generics and specialty pharmaceutical companies, with sales in approximately 140 countries and territories. And our dedication to providing access to medicine continues to grow after more than 50 years.
Qualification: Any Graduate
Experience: 1 Years
Location: Hyderabad
Industry: IT/Software
Key Skills: USFDA, EUGMP
Job Description:
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.
Qualifications:
1. Graduate degree in Pharmacy / Chemistry.
2. Minimum 1 year of experience in pharma industry.
3. Application knowledge of Regulatory requirements.
4. Knowledge of Quality Management System, GMP Requirements.
5. Knowledge and experience of regulatory audits(USFDA, EUGMP etc).
Click Here To Apply Job
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