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 Lead -Technology Transfer ,Injectables - 17000423
Job Description:
- Monitor execution of trial, scale up, optimization, exhibit and process validation batches and preparation of concerned Reports
- Ensure that work allocation for routine activities is performed as per plan
- Review and approve new processes and process controls to make sure there is no impact on product quality and process parameters
- Verify data to substantiate claims regarding the safety and efficiency of products
- Responsible for review and approval of formulae, specifications and label declarations, to ensure compliance with the finished product specifications
- Responsible for review of hold time protocols for API source change and new product development activities
- Verify development data, Master Formula Record (MFR) and specifications for new product development activities
- Perform review of risk assessment for respective site for technology and site transfer activities
- Verify the specification data and compatibility studies for API source change and new product development activities
- Verify feasibility trials for site transfer and API source change activities.
- Ensure closure of all phases (as applicable) of Protocol for Execution of Trial Batch (PETB)
- Verify process validation protocols review data & monitoring of critical manufacturing steps for process validation activities
- Responsible for review of Master Formula Record (MFR) for API source change activities and new product development activities
- Coordinate with the cross functional team to ensure timely initiation and closure of all QMS activities and documents for the assigned area. Viz., Incident Reporting, change controls, CAPAs
- Facilitate and support training in the technical areas/SOPs to develop in-house capability.
- Report and escalate incidents, as situation demands
- Perform documentation of all the activities on a real time basis as per the GDP norms
- Perform other duties as assigned for areas as authorized by relevant SOPs
Candidate Profile
M Pharma from a premier institute.
Minimum 7 Years Experience in reputed pharma company.
Injectable experience is preferred.
Proficiency in speaking, comprehending, reading and writing English is required / preferred.
Additional Information:
Experience: 7 years
Qualification: M.Pharm
Location: Bangalore
Industry Type: Pharma/Biotech/Clinical Research
End Date: 15th May, 2017
See All Hyderabad Alerts B.Pharm Alerts M.Pharm Alerts
See All Other Jobs in our Database
PharmaTutor Magazine- Latest Issues
Subscribe to Pharmatutor Job Alerts by Email
.png)
