MSN Laboratories Released Job Openings On 02/03/2022.MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has nine API and five finished dosage facilities established across Hyderabad, USA and Myanmar
Vacancy Details:
MSN Laboratories Recruiting B Pharma,M Pharma,MSc Fresher’s & Experience For Executive / Senior Executive / Junior Manager/Executive Trainee / Executive / Senior Executive Position.Complete Details for the Executive / Senior Executive / Junior Manager/Executive Trainee / Executive / Senior Executive as follows.
Important Details :
- Location : Hyderabad/Secunderabad
- Department : Regulatory Affairs – API/Formulation Research & Development – ( FR&D )
- Openings:60
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 02/03/2022
- Mode of application :Walk In
- Time And Venue: 5th March from 9 AM onwards onwards,MSN Laboratories Pvt. Ltd, R&D Center, Pashamylaram (V), Patancheru (M), Sangareddy (D.t), Telangana 91-8452304799/4899 & 040-30438786
- Contact :91-8452304799/4899 & 040-30438786
Job Description/Skills Required
Department: Regulatory Affairs – API
Position: Executive Trainee / Executive / Senior Executive / Junior Manager / Assistant Manger / Deputy Manager
Job Profile:
1. Collecting and reviewing the documents received from various departments R&D, AR&D, QA, QC and Production etc at each and every stage of manufacturing of drug substances to minimize the errors at the time of submission to regulatory agencies.
2. Hands on experience on the preparation of DMFs and their registration processes in the major regulatory regions [US, Canada, Europe etc]..
3. Hands on experience on preparation of drug master files, Applicants Parts, Tech Pack, life cycle management [updates and amendments] and drafting of response to deficiencies and customer DMF review comments for all global regions.
4. Should have hands on experience on eCTD regulatory submission tools.
5. Should have knowledge on the requirements to respond to the deficiencies.
6. Participation in the cross functional team meetings and providing regulatory inputs to the Product Development Teams.
Job Title: Junior Manager / Assistant Manager Experience: 6 to 10 years in API RA field Education: M Sc
Department: Regulatory Affairs
Job Profile:
1. Good scientific conceptual background to the level to evaluate the processes and procedures in the area of Quality, R&D, AR&D and Production.
2. Manageable communication in English [should be able to manage regulatory and scientific discussions in the internal and external meetings and one to one interactions within the organization and with customers]
3. Manageable knowledge on the regulatory and quality guidelines from various regulatory agencies ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA etc.
4. Thorough knowledge and hands on experience on the DMF registration and marketing authorization application systems in the major regulatory regions [US, Canada, Europe etc]..
5. Hands on experience on preparation of drug master files, life cycle management and drafting of response to deficiencies and customer DMF review comments for all global regions.
6. Should have knowledge on product developmental and the quality systems to ensure the regulatory compliance.
7. Should have hands on experience on eCTD regulatory submission tools.
8. Conducting meetings for the deficiencies received from various regulatory agencies and should have knowledge on the requirements to respond to the deficiencies. Ensuring that the accurate and adequate responses are sent to the authorities within the timelines defined by agencies.
9. Thorough review and ensuring that the regulatory submissions are adequate and error free with minimum open issues and closing of open issues before filing or before the receipt of deficiencies.
10. Participation in the cross functional team meetings and providing regulatory inputs to the Product Development Teams.
11. Reviewing the documents received from various departments R&D, AR&D, QA, QC and Production etc at each and every stage of manufacturing of drug substances to minimize the errors at the time of submission to regulatory agencies.
12. Review and assessment of change controls and providing guidance to the team on proposed changes.
13. Ensuring that the regulatory databases are properly maintained and updated on time to time for each regulatory activity.
Department : Formulation Research & Development – ( FR&D )
Position : Executive Trainee / Executive /Â Senior Executive
Walk- In Drive For Formulation Research and Development – FR&D ( FR&D – Oral Solid Dosage / Liquids Oral Dosage / Injectables) Department – Formulation Division- R&D Center – Saturday 05-03-2022
Formulation R&D Department ( Formulations R&D) in Formulation Division – R&D Center.
1 ) Candidate Should have minimum 0 to 7 Years of experience in formulation development of solid oral dosage form for regulated market such as USA and Europe. Candidate should have exposure in handling various dosage forms such as tablets and capsules with exposure of scale up activities. Exposure to preparation documents such as MFR, BMR, PDR are consider as added advantage.
2 ) Candidate should have 0 to 7 Years of experience in solid oral dosage forms for regulated market such as USA, Europe, Australia, etc.. He should have exposure in handling various dosage forms like tablets and capsules (ER/SR, IR). Experience in handling MUPS project is an added advantage. He should have exposure in designing strategies, DOE/QbD based development, data compilation and interpretation, basic knowledge about bio study evaluation, etc. Should have scale up exposure for regulated markets and should have appropriate knowledge about regulated market requirement. Should have exposure in preparing and reviewing documents like PDR, MFR, BMR, etc. Supervising and knowledge about handling regulatory queries will be an added advantage
3 ) should have 0 – 7 years experience in FR&D (solids) should have knowledge in QbD & DoE & its application in Formulation Development. should have knowledge on regulatory guidance.
