Senior Officer
Rubicon Research · Indore · onsite · Posted 48d ago
Not disclosed3–5 yrsfulltimeSourced from
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About this role
Purpose
To facilitate the preparation, review, and control of GMP documentation, thereby supporting regulatory compliance, product quality, and enhancing operational efficiency through effective document preparation, control, and management.
Position / Job Title
Officer
Department
Tech Transfer (Documentation)
Reporting To
Assistant Manager
Location
Pithampur (Madhya Pradesh)
Years Of Experience
3- 5Years
Dosage Form
Solid Orals
Job Responsibilities / Deliverables
Documentation & Protocol Preparation
Preparation and review of following documents
Batch Manufacturing Records (BMR)
Batch Packaging Records (BPR)
Intended batch BMR/BPR
Process Validation Protocols/Reports (PVP/PVR)
Hold Time Study Protocols/Reports (HTSP/HTSR)
Review and control of documentation to ensure consistency in manufacturing thereby reducing errors and deviations.
Drafting and maintain of master records.
To ensure the document for production & packing activities adhering to cGMP norms and right at first time.
Process Standardization
Review, and control documentation to ensure consistency in unit operations, thereby reducing errors and deviations.
Communicate with the QA/RA to obtain any documents or required information.
To ensure closing of validation reports in a timely manner.
Coordination & Cross-Functional Support
To co-ordinate Manufacturing, QA, QC, Warehouse, and Engineering to ensure smooth and timely preparation of documents and closing of document related change controls.
Ensure availability of all tech transfer documents prior to batch execution.
Change Control
Initiate, track, and ensure the timely closure of Change Controls related to document revisions.
Assist in the preparation of data and documents for regulatory submissions and audits.
Qualifications & Pre-requisites
B. Pharm / M. Pharm
Knowledge of unit operations involved in manufacturing and packing of solid oral dosage forms i.e. Granulation, Blending, Compression, Coating, Capsulation, Packing etc.
Basic knowledge of QMS/documentation (change control, document/Protocol/BMR/BPR preparation/review etc.)
Additional Notes
Role is expected to work in all shifts.
To facilitate the preparation, review, and control of GMP documentation, thereby supporting regulatory compliance, product quality, and enhancing operational efficiency through effective document preparation, control, and management.
Position / Job Title
Officer
Department
Tech Transfer (Documentation)
Reporting To
Assistant Manager
Location
Pithampur (Madhya Pradesh)
Years Of Experience
3- 5Years
Dosage Form
Solid Orals
Job Responsibilities / Deliverables
Documentation & Protocol Preparation
Preparation and review of following documents
Batch Manufacturing Records (BMR)
Batch Packaging Records (BPR)
Intended batch BMR/BPR
Process Validation Protocols/Reports (PVP/PVR)
Hold Time Study Protocols/Reports (HTSP/HTSR)
Review and control of documentation to ensure consistency in manufacturing thereby reducing errors and deviations.
Drafting and maintain of master records.
To ensure the document for production & packing activities adhering to cGMP norms and right at first time.
Process Standardization
Review, and control documentation to ensure consistency in unit operations, thereby reducing errors and deviations.
Communicate with the QA/RA to obtain any documents or required information.
To ensure closing of validation reports in a timely manner.
Coordination & Cross-Functional Support
To co-ordinate Manufacturing, QA, QC, Warehouse, and Engineering to ensure smooth and timely preparation of documents and closing of document related change controls.
Ensure availability of all tech transfer documents prior to batch execution.
Change Control
Initiate, track, and ensure the timely closure of Change Controls related to document revisions.
Assist in the preparation of data and documents for regulatory submissions and audits.
Qualifications & Pre-requisites
B. Pharm / M. Pharm
Knowledge of unit operations involved in manufacturing and packing of solid oral dosage forms i.e. Granulation, Blending, Compression, Coating, Capsulation, Packing etc.
Basic knowledge of QMS/documentation (change control, document/Protocol/BMR/BPR preparation/review etc.)
Additional Notes
Role is expected to work in all shifts.
Sourced from foundit
Skills
cGMP normsRegulatory submissions and auditsQMS DocumentationChange Controlbatch manufacturing recordsGMP documentationBatch Packaging Records (BPR)
About Rubicon Research
Rubicon Research
Pharma
1.1k+
employees
1999
27 years old
Atlanta,Georgia
United States
About
Rubicon has built and expanded on strong strategic partnerships primarily regarding Development, Manufacturing, and Regulatory Support of Pharmaceutical Products.
Industries
PharmaInternet
Employee ratings
375 reviews
3.4/ 5
Culture
3.2
Career growth
3.0
Work-life
3.1
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