Work as CQA Executive- Tablet/ Capsule and Ointment products @ Evolet Healthcare
Evolet Healthcare Pvt. Ltd. is an international, modern and dynamic outsourcing company that specializes in the field of contract manufacturing and marketing of pharmaceutical products. The Management of the company constantly monitors innovations in the pharmaceutical industry to keep up with the ever-increasing demands on pharmaceutical products to improve and enhance the quality of services irrespective of which part of the world the client comes from. Evolet Healthcare Pvt. Ltd. has long-term contracts with manufacturers of pharmaceutical products, as well as with international pharmaceutical corporations and marketing companies that distribute its products in the markets of Asia, EU, CIS, Africa and Latin America.
Post: CQA Executive- Tablet/ Capsule and Ointment products
Job Description
• Preparation of Dossiers - CTD (Common Technical Dossier) and ACTD (Asian Common Technical Dossier).
• To do Gap Analysis & Reviewing documents received from plant QA/QC & maintaining records.
• To do Gap Analysis in the Loan License / Third party data for dossier requirement.
• Co-ordination with plant - production & packing for samples and documents.
• Abreast with current guidelines of registration of different countries and share with team.
• Handling queries & deficiencies received from Authorities.
• Reviewing of documents received from CROs, FR&D ADL.
• Checking data like Stability, Specification & Standard Test Methods, Standard Operating Procedure, Certificate of Analysis, Checking MFR & BMR for correct calculations.
• Visiting Mfg. Plant for the data required for submission and interaction with QA/QC.
• Reviewing the dossiers prepared by team members before submitting to Authorities / Agent and taking the complete responsibility of error free dossiers.
• Regulatory work status to be maintained and weekly updates to be reported to HOD.
Candidate Profile
• Exposure to Pharma Companies/Formulation dept./Production/QC/QA Depts.
• Proper understanding of Pharmaceutics and Pharmacology.
• Technically Comprehensive.
• Fine Analytical Skills and Systematic approach.
• Proactive approach to problem solving.
• Thorough Knowledge of GMP Practices.
• Engrossment in job related work-enjoying his work.
• Good computation Skills.
• Strong and consistent.
• Logical Interpretation of Data.
• Ability of multi-tasking.
Additional Information:
Experience: 5-6 Years
Education: B.Pharm with PGDPRA or M.Pharm
Location: Gurgaon
Fucntional Area: DRA
Industry: Healthcare/Pharma/Biotech
Last Date: 20th July, 2015
Interested candidates can send their CV at vacancy@evolet.in
Evolet Healthcare Pvt. Ltd. is an international, modern and dynamic outsourcing company that specializes in the field of contract manufacturing and marketing of pharmaceutical products. The Management of the company constantly monitors innovations in the pharmaceutical industry to keep up with the ever-increasing demands on pharmaceutical products to improve and enhance the quality of services irrespective of which part of the world the client comes from. Evolet Healthcare Pvt. Ltd. has long-term contracts with manufacturers of pharmaceutical products, as well as with international pharmaceutical corporations and marketing companies that distribute its products in the markets of Asia, EU, CIS, Africa and Latin America.
Post: CQA Executive- Tablet/ Capsule and Ointment products
Job Description
• Preparation of Dossiers - CTD (Common Technical Dossier) and ACTD (Asian Common Technical Dossier).
• To do Gap Analysis & Reviewing documents received from plant QA/QC & maintaining records.
• To do Gap Analysis in the Loan License / Third party data for dossier requirement.
• Co-ordination with plant - production & packing for samples and documents.
• Abreast with current guidelines of registration of different countries and share with team.
• Handling queries & deficiencies received from Authorities.
• Reviewing of documents received from CROs, FR&D ADL.
• Checking data like Stability, Specification & Standard Test Methods, Standard Operating Procedure, Certificate of Analysis, Checking MFR & BMR for correct calculations.
• Visiting Mfg. Plant for the data required for submission and interaction with QA/QC.
• Reviewing the dossiers prepared by team members before submitting to Authorities / Agent and taking the complete responsibility of error free dossiers.
• Regulatory work status to be maintained and weekly updates to be reported to HOD.
Candidate Profile
• Exposure to Pharma Companies/Formulation dept./Production/QC/QA Depts.
• Proper understanding of Pharmaceutics and Pharmacology.
• Technically Comprehensive.
• Fine Analytical Skills and Systematic approach.
• Proactive approach to problem solving.
• Thorough Knowledge of GMP Practices.
• Engrossment in job related work-enjoying his work.
• Good computation Skills.
• Strong and consistent.
• Logical Interpretation of Data.
• Ability of multi-tasking.
Additional Information:
Experience: 5-6 Years
Education: B.Pharm with PGDPRA or M.Pharm
Location: Gurgaon
Fucntional Area: DRA
Industry: Healthcare/Pharma/Biotech
Last Date: 20th July, 2015
Interested candidates can send their CV at vacancy@evolet.in
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