Metrochem API Pvt Ltd was established by Dr. N.V. Rao in the year 2004, with a grand vision of being the most preferred supply partner to pharmaceutical customers worldwide. The management aimed to achieve this vision with a clear focus on quality, affordability and products at Metrochem API Private Limited is one of the fastest growing manufacturers of Active Pharmaceutical Ingredients (APIs), Pellets (Semi finished Formulations) and Intermediates.
Metrochem API Walk In
Qualification: MS/M.Sc(Science) in Chemistry
Experience : 00-02+years
Department: API Regulatory Affairs
Role: Jr Manager/ Asst Manager
Job Location: Hyderabad/ Secunderabad,Telangana( Shapur Nagar )
No.of Openings: 02
Time and Venue
26 June – 30 June , 10.00 AM – 5.00 PM
Metrochem API -Unit-R&D, Rangabhujanag Theatre Lane, Shapurnagar, Hyderabad.
Contact – Gowtham ( 8187892413 )
Job description:
Position for – Jr Manager/ Asst.Manager – API Regulatory Affairs -Unit-R&D, Shapurnagar, Hyderabad.
Qualification – Only M.Sc. Chemistry
Experience – 7-10 years (API – RA)
Walk In
Venue – Unit-R&D, Rangabhujanga Theatre Lans, Shapurnagar, Hyderabad
Dates – 26-06-2023 to 30-06-2023
Time – 10am to 5 pm
Contact Number- 8886659021 / 8187892413
Email CV’s to – gowtham.adapa@metroapi.com
For further assistance contact – 8187888831.
JOB DESCRIPTION
1. Examining the conformity of all documents for approval must be compliant to all relevant regulations,
rules and standards and taking part in the conformity assessment procedure with coordination of all
concerned departments.
2. Developed and maintained an in dept , ongoing knowledge of Guidelines, Regulations, Directives and requirements for submission.
3. Communicate regulatory information to multiple departments and ensure that information is
interpreted correctly and support the relevant departments in fulfilling the regulatory requirements
4. Handling of Authority and Customer Queries.
5. DMF or Dossier Preparations and submission.
6. Providing the regulatory strategic note for building the product by exploring various literature and
summary basis of approval provided by various regulatory authorities.
7. To provide the regulatory in-puts for the change controls assigned.
8. Make sure the proper regulatory data base maintenance.
9. Building the regulatory awareness.
10. Genotoxic impurities assessment and control strategy.
11. Nitrosamine risk assessment evaluation.
12. New DMF and amendment review in technical aspect and regulatory compliance.
13. Serves as a liaison between the regulatory bodies and operating devisions of the company.
14. Tracking and monitoring the process of submissions.
15. Enriching the quality of documents in-line with the current regulations.
16. Regulatory Compliance Facilitate quick closure of internal and external outstanding regulatory issues.
17. Regulatory intelligence Responsible for assessment of regulatory consultants and trade consortium
18. Team empowerment Responsible for mentoring reportees
19. Team empowerment Responsible for identifying appropriate training for the team.
20. Technical and managerial skills to understand and guide cross functional teams on process development, analytical development , process scale up , product characterizations.
21. Experience and expertise to develop regulatory strategy from development stage to filing and
approval.
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