Executive Sr Executive Pharmaceuticals
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Job Description
About the job
FinOrion Pharma India Pvt. Ltd. is looking for an Executive / Sr. Executive Pharmaceuticals in Pharmaceuticals department. In this position you will be based in Mumbai.
Description Of Position
Responsibilities:
- Writing of Product Quality Review (PQRs) for own production products ensure its timely approval.
- Preparation and review of other documents related to PQRs.
- Requesting followup and tracking of PQR related data.
- Review of externally supplied PQRs related coordination and follow up with vendor and other stakeholders.
- Reviewing and commenting on change controls deviations temperature excursions stability data process validation documents troubleshooting etc. for ESO products.
- To evaluate dossiers and suggest the additional requirements (if any) for probable new market.
- Responsible for planning stability studies writing and/or review of stability protocols reports and preparation of technical documents in CTD format.
- Coordinate and follow up stability studies at CROs/CQC
- Writing and/or reviewing of process validation technology transfer study batch documentation for own products
- Write/check/review pharmaceutical documents as per regulatory requirements.
- Write documents into Orions IT systems.
- Preparation and maintenance of lists/documents/records and archiving at appropriate place.
- Coordination with other departments / partners
- Achievements of responsibilities within the agreed timelines
- To assist the overall working of Indian Pharmaceutical team
- Other tasks appointed by Supervisors
- Note: We do not have own laboratories in India!
Description Of Unit
Global Operations is one of the core areas of operations in Orions India office. This office is involved in procurement of inlicensed formulated products and pharmaceutical ingredients for inhouse manufacturing in Finland. The Packaging Technology team is involved in creating and managing artworks for both inlicensed and inhouse manufactured products. The Quality assurance team is involved in auditing our partners globally for ensuring cGMP compliance.
CPD LCM India (Pharmaceuticals and Regulatory Affairs teams) supports the product life cycle management maintenance of marketing authorizations various other documentation requirements and supports activities such as biostatistics programming and medical writing tasks for regulated markets. The Creative Design team in India supports digital / graphic designing activities.
We offer
- An excellent opportunity to work in an inspiring and important role in the area of Pharmaceuticals
- 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 professionals
- Flexible high spirit working environment where your skills are appreciated
- Hybrid Work Policy (In a week 3 days work from office and flexibility to work remotely for two times).
- Good worklife balance
- Clear transparent processes and responsible supervisors are our benefits to the personnel
Requirements
- Bachelors / Masters degree in Pharmacy from a reputed College / University
- Minimum 4 years experience in Formulation RD activities in global Pharma industry
- Confirmed knowledge of EU requirements and ICH guidelines
- Candidate having interest and/or experience in pharmaceuticals documentation or any relevant pharmaceutical formulation / manufacturing related documentation will be preferred.
- Practical development skills from the laboratory to the production scale concerning diverse types of formulations (tablets capsules liquids etc.) will be considered as an added advantage.
- Proactiveness and problem solving abilities
- Fluency in oral and written English
- Task oriented with learning attitude and Teamwork skills
- Confirmed skills of Microsoft Office is essential
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Remote Work :
No
Employment Type
Full Time
