Executive- Analytical
Executive- Analytical
Posted on :
13-06-2025
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1 Vacancy
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Job Description
Description
Roles and Responsibilities
- Coordinate and follow-up with internal and external partner to review and evaluate Nitrosamine impurity and ensuring compliance to relevant guidelines.
- Managing and developing the process for Excipient GMP risk evaluation including maintenance of the structure with functionalities.
- Review elemental impurities statement its impact on final product andensuring compliance.
- Responsible for planning stability studies writing and/or review of stability protocols reports and preparation of technical documents in CTD format.
- Co-ordinate and follow up stability studies at contract research organizations (CROs)/ Chemical Quality Control lab of Orion (CQC).
- Co-ordinate and follow up validation and method transfer at CROs.
- Write/check/review analytical and pharmaceutical documents as per regulatory requirements (method and validation documents/ variations/ additional question responses)
- Evaluate/ review method validation protocols / reports / analytical methods prepared by CROs.
- Reviewing and commenting on change controls deviations temperature excursions stability data process validation documents and troubleshooting etc. for externally supplied products.
- Write documents into Orions IT systems for example analytical methods
- Writing of Product Quality Review (PQRs) for own production products and ensure its timely approval.
- Preparation and review of other documents related to PQRs.
- Requesting follow-up and tracking ofPQR related data.
- Review of Externally supplied PQRs related coordination and follow up with vendor andand otherstakeholders
- Theoretical evaluation of physico-chemical properties of the drug products and/or raw materials
- Co-operation with other departments/ partners
- Local in-licensing support
- To assist the overall working of Indian Pharmaceutical team
- Other possible tasks appointed by Supervisors
- Note: We do not have own laboratories in India!
Primary Skills (Essential)
- Minimum 4 years work experience in Analytical Development or Pharmaceutical product development or Quality Assurance activities in global Pharma industry
- Knowledge of EU and US requirements and ICH guidelines
- Practical development skills from the laboratory work and troubleshooting
- Task oriented with learning attitude and Teamwork skills
- Fluency in oral and written English
- Confirmed skills of Microsoft Office is essential
- Pharmaceutical education & practical analytical development skills also from the laboratory to production scale of different types of formulations (tablets capsules liquids etc.) will have added advantage
- Candidate interested/experienced in above documentation work will be preferred.
This Job offers
- An excellent opportunity to work in an inspiring and important role in the area ofPharmaceuticals
- Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group
- Possibility to utilize your own strengths with the support of the professionals
- Flexiblehigh spiritworking environment where your skills are appreciated
- Good work-life balance
- Clear transparent processes and responsible supervisors are our benefits to the personnel
Education
- Masters degree in chemistry from a reputed College / University
At Orion your work creates true impact and well-being for our customers patients and society at culture of friendliness respect mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.
Please visit our website to find further information about our values and Orion as an employer to apply and additional information
- Please fill Candidate Information Formon email your CV to
- Required documents: CV/Resume
- Application deadline: 05.07.2025
Employment Type
Full-Time
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