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Sr Manager/Manager -CQA
10-12 years
Noida, Greater Noida
1 vacancy
Sr Manager/Manager -CQA
Jubilant Enpro
posted 27d ago
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Fixed timing
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Job Description
Jubilant Bhartia Group
Jubilant Pharmova Limited
Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses.
In the Radiopharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US. The Company s Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectables business offers manufacturing services including sterile fill and finish injectables (both liquid and lyophilization), full-service ophthalmic offer (liquids, ointments & creams) and ampoules.
The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centres in Bangalore and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and autoimmune disorders. The company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies.
The Position
Organization- Jubilant Pharmova Limited
Designation - Sr. Manager/ Manager CQA
Location- Noida
Job Summary: This role involves reviewing analytical related documents ,batch records, conducting internal audits of Active Pharmaceutical Ingredient (API) and Oral Solid Dosage (OSD) facilities, and troubleshooting analytical issues related to tech transfer. This will involve compliance execution activities of tech transfer ,Method Verification, Method Validation support and Standard Test Procedures (STPs).
Key Responsibilities.
- Review and approve method transfer protocol /reports ,specifications and STPs.
- Lead and manage method verification and method validation support.
- Oversee the review of batch records to ensure compliance with regulatory standards.Conduct audits of API , OSD and external CMOs facilities to ensure adherence to quality standards.
- Troubleshoot and resolve analytical issues related to tech transfer processes.Ensure all tech transfer activities comply with regulatory requirements and company policies.
- Implement and maintain quality systems to support tech transfer activities. Collaborate with cross-functional teams to ensure seamless tech transfer processes.
- Maintain accurate and up-to-date records of all tech transfer activities. Ensure regular updates and reporting to senior management on the status of tech transfer projects.
Person Profile .
Qualification - Masters degree in Pharmaceutical Sciences/ Chemistry.
Experience 10-12- Yrs in Pharma Tech Transfer, with a focus on Method Verification and Validation.
Desired Certification & Must Have -
- Experience with internal audits and Quality assurance in API and OSD facilities. Proficiency in troubleshooting analytical issues related to tech transfer.
- Familiarity with regulatory guidelines and industry best practices.
Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances.
Employment Type: Full Time, Permanent
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What people at Jubilant Enpro are saying
Senior Manager salary at Jubilant Enpro
reported by
1
employee
with 12
years exp.
₹21.6
L/yr - ₹27.6
L/yr
15%
more
than the average Senior Manager Salary in India
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What Jubilant Enpro employees are saying about work life
based on 26 employees
Strict timing
Monday to Friday
No travel
Day Shift
Jubilant Enpro Benefits
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