MSN Laboratories (MSN Group) is one of the fastest growing manufacturers of Active Pharmaceutical Ingredients (APIs) and Finished dosages in India. Established in the year 2003, MSN Group comprises of eight API manufacturing plants ( including one for Oncology), two finished dosage facility ( one more for Oncology being built) and a dedicated R&D Center and is growing 30-40% every year. Our plants are ISO 9001-2000 certified, WHO: GMP, EU:GMP and USFDA approved. Our manufacturing units are designed to confirm to the principles of Quality, Safety and sound Environment.
Walk- In Drive for Formulation Analytical Research & Development (FAR&D) Department .in MSN R&D Center, Saturday 16-07-2022 at MSN R&D Center Pashamylaram.
JOB DESCRIPTION:
Experience : Minimum 1 to 13 Years experience in Formulation AR&D ( FAR&D ) Department.
Analytical Method Development , Analytical Method Validation , HPLC, GC-MS , LC MS, Complex Injectable , OSD , Liquids, oncology, Formulation Analytical Quarries, analytical documentation, analytical support,
- Should have 2-10 years of adequate hands on experience in performing analysis of special oral dosage forms such as Suspensions, Solutions/Syrups, and Powders/granules for Oral suspensions.
- Should have experience in Method development and method validation along with support and stability studies of suspensions and Solutions.
- Should have hands on experience in handling analytical instruments such as, not limited to Dissolution, High Performance chromatography, Gas Chromatography, Karl-Fischer Instrument, IR spectroscopy, Viscometer.
- Should possess adequate analytical skills to perform tests like Assay, Dissolution, Related substances, Residual solvents, pH and specific gravity measurements, Suspendability and redispersibility, Sedimentation velocity, Pourability, Viscosity, flocculation and de-flocculation etc.
- Should have strong desire for analytical research-orientated work and assignments.
- Should have technical knowledge and capability in interpreting analytical data and results
- Should be able to work collectively and collaboratively with in team and analytical department.
- Should able to work and adhere strictly to quality and compliance policies of company by following SOP and STP.
Position : Junior Executive / Executive / Senior Executive / Junior Management /Assistant Manager
- Qualification : BSc / B Pharma / M Pharma / MSc
- Department : Formulation Analytical Research & Development (FAR&D)
Date of Interview : 16.07.2022 ( Saturday )
Interview Time : 9.00 AM to 1.00 PM
Work Location : MSN R&D Center, Pashamylaram.
Venue Details :
MSN Laboratories Pvt. Ltd, R&D Centre, Pashamylaram (V), Patancheru (M), Sangareddy (D.t), Telangana
Walk-In Drive For for API -Regulatory Affairs -Department in API Division – MSN R&D Center Pashamylaram, On Saturday 16-07-2022.
Regulatory Affairs API RA Department in API Division ,
Job Description: ( Regulatory Affairs – API Division )
- Should have minimum of 2 to 15 years of experience in API Regulatory Affairs
- Job Title: Executive / Senior Executive / Junior Manager :- Experience: 2 to 10 years in API RA field
- Education: MSc – Chemistry Should have minimum of 2 to 15 Years
- Department : Regulatory Affairs
- Job Title: Executive – Manager Experience: 2 to 15 years in API RA field Education:
- Department: Regulatory Affairs – API
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.
Interview Date : 16-07-2022
Department : Drug Regulatory Affairs API RA Dept.
Experience : 2 to 15 Years
Position: Executive / Senior Executive / Junior Manager / Assistant Manger / Deputy Manager / Manager
Work Location : MSN R&D Center, Pashamylaram.
Venue: MSN Laboratories Pvt. Ltd,
R&D Center, Pashamylaram (V), Patancheru (M), Sangareddy (D.t), Telangana
91-8452304799/4899 & 040-30438786
More Job Updates Join What’s App Group – Click Here
Join Telegram Group – Click Here