Experience: 4 to 8 yrs.
Subject Line in Mail should be QA_Name, failing this the CV will not be considered / downloaded at all
To maintain compliance to established Quality System on API production unit.
- Documentation and internal inspection to maintain the QA system
- Preparation of SOPs, STPs, BMR, annual report, and GMP related documents.
- Strong compliance & filing activities related to cGMP, US DMF.
- Knowledge Of Regulatory Documentations like specifications, COA, MOA, Method Validations, Cleaning Validation, WHO documentation, Master formula, etc.
- Production site audit to manage API manufacturing activity.
- Documentation and internal inspection to maintain the QA system
- Preparation of SOPs, STPs, BMR, annual report, and GMP related documents.
- Strong compliance & filing activities related to cGMP, US DMF.
- Knowledge Of Regulatory Documentations like specifications, COA, MOA, Method Validations, Cleaning Validation, WHO documentation, Master formula, etc.
- Production site audit to manage API manufacturing activity.
1. 4 -8 years experience in the Pharmaceutical Industry in any of the top Pharma Companies and have audit experience with USFDA & MHRA
2. Experience working for writing, review and filing a US DMF(at least 10 APIs) and its related submission.
3. Should be self motivated and result oriented.
4. Should be initiator, keen learner, proactive and good analytical skills.
5. Ability to multitask and prioritize responsibilities.
6. Must be Proficient in written, verbal, Computer skills and business communication.
7. M.Sc. (Chemistry) or M.Pharm
8. Marital status Any (Single / Married)
9. Employee has to stay alone and work, if married, family is not allowed to stay in Korea.
Salary will be comparable to industry standards in India. Please e-mail detailed resume giving complete details of the last drawn salary and expected salary at: daewoong_pharm@yahoo.co.in
2. Experience working for writing, review and filing a US DMF(at least 10 APIs) and its related submission.
3. Should be self motivated and result oriented.
4. Should be initiator, keen learner, proactive and good analytical skills.
5. Ability to multitask and prioritize responsibilities.
6. Must be Proficient in written, verbal, Computer skills and business communication.
7. M.Sc. (Chemistry) or M.Pharm
8. Marital status Any (Single / Married)
9. Employee has to stay alone and work, if married, family is not allowed to stay in Korea.
Salary will be comparable to industry standards in India. Please e-mail detailed resume giving complete details of the last drawn salary and expected salary at: daewoong_pharm@yahoo.co.in
Subject Line in Mail should be QA_Name, failing this the CV will not be considered / downloaded at all
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