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Multiple Vacancies in Various Departments-Biosimilar Manufacturing Team at Kwality Pharmaceuticals Ltd.
Join Biosimilar Manufacturing Team at Kwality Pharmaceuticals Ltd.
Kwality Pharmaceuticals Ltd. are expanding our team and seeking talented professionals to be part of our Biosimilar Manufacturing Plant in Amritsar. If you're passionate about biologics and biosimilar production, have exciting opportunities for you!
Open Positions and Requirements:
1. QA Specialist – Qualification (4-6 years)
-Expertise in equipment qualification (IQ, OQ, PQ) and utilities validation in view of biologics manufacturing.
-Ability to prepare and review qualification protocols and reports.
-Track periodic calibrations and validations.
2. QA Officer – Regulatory Submission (1-3 years)
-Experience in preparing regulatory submissions for biosimilars (e.g., CTD, ACTD).
-Understanding of domestic and global regulatory guidelines (RCGM, DCGI, etc.).
-Proficiency in compiling and reviewing quality and technical documents for submissions.
-Familiarity with post-submission activities such as addressing regulatory queries.
-Support QMS activities.
3. IPQA Specialist (2-3 years)
-Hands-on experience in in-process quality assurance activities in biosimilar manufacturing.
-Expertise in line clearance, batch release processes and monitoring of manufacturing processes to ensure compliance with GMP.
-Good documentation practices and experience in preparing in-process checklists.
4. Production Documentation Specialist (4-6 years)
-Expertise in preparing Batch Manufacturing Records (BMR), Master Formula Records (MFR), and SOPs for biosimilars.
-Experience in writing protocols and reports for Process Validation and Cleaning Validation.
-Knowledge of regulatory expectations for production documentation.
-Proficiency in coordinating with production and QA teams to ensure documentation accuracy.
-Familiarity with deviations, CAPA, and document control systems.
5. Production Documentation Officer (1-3 years)
-Hands-on experience in preparing and maintaining production-related documents for biosimilars.
-Basic understanding of Process Validation and Cleaning Validation documentation.
-Ability to review and ensure completeness of BMRs and MFRs.
Location: Biological Division, Kwality Pharmaceuticals Ltd., Amritsar.
If you or someone you know fits the bill, please send your CV to hrd@kwalitypharma.com.
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