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: DGM - API Quality Assurance
Job Description:
• Prepare controlled documents and distribute, retrieve, archive and destruct controlled documents. Support for DMF/ANDA filing and regulatory queries and prepare new documents as per cGMP requirement, as and when required.
• Prepare employee training curriculum, annual schedules and coordinate with internal trainers and execute the training as per schedule. Maintain, check and update the training records. Assess the training evaluation questionnaires and conclusion of 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 and execute the approved changes as per the action plan. Prepare the validation protocols and reports and 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 and initiate the vendor evaluation documents. Maintain master data SAP related to vendor.
• Prepare the APQR report and summarize the data collected in APQR preparation, as well as assist the supervisor in preparing recommendations based on APQR evaluation.
• Prepare controlled documents and distribute, retrieve, archive and destruct controlled documents. Support for DMF/ANDA filing and regulatory queries and prepare new documents as per cGMP requirement, as and when required.
• Prepare employee training curriculum, annual schedules and coordinate with internal trainers and execute the training as per schedule. Maintain, check and update the training records. Assess the training evaluation questionnaires and conclusion of 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 and execute the approved changes as per the action plan. Prepare the validation protocols and reports and 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 and initiate the vendor evaluation documents. Maintain master data SAP related to vendor.
• Prepare the APQR report and summarize the data collected in APQR preparation, as well as assist the supervisor in preparing recommendations based on APQR evaluation.
Candidate Profile
- Graduate degree in Pharmacy/ Chemistry
- Minimum 4 years of experience in pharma industry
- Application knowledge of Regulatory requirements; Qualifications and Validations
- Knowledge of Quality Management System
- Knowledge of GMP Requirements
- Knowledge and experience of regulatory audits (USFDA, EUGMP etc)
- Proficiency in speaking, comprehending, reading and writing English
- Graduate degree in Pharmacy/ Chemistry
- Minimum 4 years of experience in pharma industry
- Application knowledge of Regulatory requirements; Qualifications and Validations
- Knowledge of Quality Management System
- Knowledge of GMP Requirements
- Knowledge and experience of regulatory audits (USFDA, EUGMP etc)
- Proficiency in speaking, comprehending, reading and writing English
Additional Information:
Experience: 4 years
Qualification: Degree in Pharmacy/ Chemistry
Location: Andhra Pradesh-Hyderabad
Industry Type: Pharma/Biotech/Clinical Research
Experience: 4 years
Qualification: Degree in Pharmacy/ Chemistry
Location: Andhra Pradesh-Hyderabad
Industry Type: Pharma/Biotech/Clinical Research
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