Opening For Assistant Manager For Quality
- Rubicon Formulation
- 4 - 9 years
- Aurangabad
- 4 years ago
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Job Description
Preparation and review of Batch record (BMR, BPR)
Developed expertise in QA documentation including handling of Deviation & change control.
Have sound Knowledge of QMS Module & Citrix Inventory System.
Developed skill in preparation and review of Qualification/Validation Protocol & Reports (IQ, OQ, PQ).
Document control (Issuance, Retrieval, Storage and destruction of BMR, BPR, specification, SOP).
Carried out online maintenance of documents.
Execution of Equipment Qualification studies in coordination with other departments.
Monitoring Finished product control samples and issuance of stability sample for charging.
Preparation of Manufacturing Process for MFR, Plant Troubleshooting documents.
Preparations of dossiers for tech pack submission and regulatory requirements.
Time to time review of SOPs & change controls related to all departments.
Carried out online maintenance of documents, issuance and retrieval of R & D Note Books.
Successful coordination for documentary support from R & D during USFDA AUDIT
Played a key role as coordinator for compilation and submission of dossier/registration documents to regulatory team from plant.
Submitting compliance documents and Justifications to RA Dept time to time for Query received from different clients & authorities;
Preparation of cleaning validation worst case matrix, Protocol & Report preparation for Cleaning validation, CEHT & DEHT studies
Implementing & reviewing of document for APQR, Change controls, SOPs, BMR, P&G Technical standards for adequacy and compliance, Investigation reports, Formulations checking as per product permission before approval from QA head.
Preparation of Product development report for MDI, Protocol & Report for Comparative evaluation of Innovator and product for regulatory submission.
Effectively handling of FDA WHO GMP site for application & granting of COPP.
Developing second line for QA related functions; artwork checking, tracking and executing requirements for Process validation batches and Stability studies of MDI formulations.
Coordinating with QA team members for audit documents preparation and compilation during WHO GMP, TFDA, Philippines & Kenya audit, BPOM Indonesia,
Coordinating self inspection team as internal Auditor
Prepared Risk assessment program for MDI formulations & cleaning validation, imparting training & documentation practices.
Job Classification
Industry: Pharma / Biotech / Clinical ResearchFunctional Area: Other,
Role Category: Other
Role: Other
Employement Type: Full time
Education
Under Graduation: B.Sc in Any Specialization, B.Pharma in Pharmacy, Other GraduatePost Graduation: MS/M.Sc(Science) in Any Specialization, M.Pharma in Pharmacy
Doctorate: Doctorate Not Required
Contact Details:
Company: Rubicon Formulation Pvt LtdLocation(s): Aurangabad
Website: https://www.rubiconindia.com
Keyskills: QA Change Control Cleaning Validation Process Validation QMS Equipment Qualification Bmr Deviation Quality Assurance Auditing
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