Unison Pharmaceuticals Pvt Ltd Job Opening For Formulation/ Analytical Development (Regulated Market)
 |
| Unison Pharmaceuticals Pvt Ltd Job Opening For Formulation/ Analytical Development (Regulated Market) |
Opening For Analytical Development Lab (Regulated Market) at Unison Pharmaceuticals Pvt Ltd
Experience: 2 - 4 Years
Job location: Ahmedabad(Moraiya), gujarat
Job Highlights
Perform analytical Method development for various dosage forms of formulation products with proper documentation and prepare Analytical test procedure
Candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements
Job Description
Opening For Analytical Development Lab (Regulated Market)
Key Accountabilities/ Responsibilities
Conduct literature survey and prepare details related to Columns, impurities, standards and chemicals requirement.
Discuss with group leader and put request for procurement, if materials are not available.
Perform analytical Method development for various dosage forms of formulation products with proper documentation and prepare Analytical test procedure; Assay, Dissolution, Related substances, Content uniformity (Based on product requirement), Blend uniformity and Working standard preparation as per SOP.
Online usage record maintenance of Working standard, Impurity reference standard, reagents, chemicals, solvents etc.
Perform F&D trial sample analysis and Stability sample analysis with proper data compilation.
Guide junior team members for performing method development and perform troubleshooting.
Prepare Standard Test Procedure (STP) and get the document reviewed by group leader.
SOP preparation related to instrument operation and documentation.
Perform analytical method transfer as per SOP with proper documentation.
Support Quality Control team in executing tests based on Standard Test Procedure during method transfer.
Online record maintenance of instrument and column usage.
Perform data integration for all analysis.
Maintain log related to reference standard and impurity standard.
Operation of machines and equipment like; HPLC (High Performance Liquid Chromatography), UV Spectrophotometer, Dissolution Apparatus, Disintegration tester and Hardness tester etc.
Perform troubleshooting related to instruments.
Perform Instrument calibration as per respective SOP; Daily Balance Verification, Daily pH meter calibration and HPLC calibration.
Review of analytical data generated in analytical development laboratory.
Candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements.
Interested candidates may also email their resume to career@unisonpharmaceuticals.com
2) Opening For Formulation Development (Regulated Market) at Unison Pharmaceuticals Pvt Ltd
Job Description
Education
B.Pharma in Any Specialization
MS/M.Sc(Science) in Any Specialization, M.Pharma in Any Specialization
Job Highlights
Master Formula Card (MFC),Finished product specification,Packing Record request,RM / PM Specification etc
Perform exhibit batch execution along with Tech Transfer team
Experience: 2 - 4 Years
Job Location: Ahmedabad(Moraiya)
1. Primary Development Stage
Review and Initiate & Guide formulation development activities for emerging and domestic market projects allocated to him and to the team scientist.
Receives New Product Development details from Section head- F&D and initiate the process of product development.
Strategy Discussion of new project timeline and development.
Application preparation for manufacturing license, test license, import license and validated with F&D section head
Carryout Literature search on APIs, Formulation, Patent search, Selection of Excipients, Technologies for the development of Solids oral dosage form (Tablets: IR, DR & ER dosage forms & Capsules: Powder and Pellets filled) and developing non-infringing formulae and manufacturing process.
Prepare Product Development strategy and discuss the journey in consent with Section head and R&D head.
Carryout Pre-formulation studies like; Formulation and excipient screening and compatibility studies, selection of excipients and feasibility trials for process selection and tablet shape and size selection.
Prepare application for trade dress approval.
Handle equipment like RMG, Fluid Bed Processor (FBP), Fluid Bed Dryers (FBD), Multi mills / co mills, Blenders, compression machine, auto coater and capsule filling machines during product development.
Review and strategized all the above mentioned Primary Development related activities of all the projects allocated to team Scientist.
2. Secondary Development Stage
Carryout Optimization of formulation development which includes various key activities like; Trials and error, Dissolution Optimization, OPD study, Stability study, Process optimization and finalization and scale up batches.
Responsible for submission of trials and stability batches for analytical analysis (e.g. Dissolution, Assay, Related Substances, Content Uniformity etc.)
Responsible for stability protocols preparation, compilation, review and interpretation of stability results.
Carryout scale up batches with Technology Transfer team to demonstrate feasibility and robustness of the formulation and selected manufacturing process.
Perform exhibit batch execution along with Tech Transfer team.
Review and strategized all the above mentioned Secondary Development related activities of all the projects allocated to team Scientist.
3. Documentation
Preparation and review of laboratory note books.
Preparation of various documentations like; Master Formula Card (MFC), Finished product specification, Packing Record request, RM / PM Specification etc.
Preparation of final Product Development Report (PDR) which broadly includes; Drug substance details, Pre-formulation studies, Product development details, Innovator characterization, Stability studies, Packing details, Microbial attributes and Packing / Container closure details.
Review all the documents of all the projects allocated to team Scientist.
4. Cross functional support
Partner with Technology Transfer, manufacturing and other support team and extend specialization to resolve any product related issues.
Extend cross functional support to RA and share Product Development Report for dossier preparation.
Conducting the trouble shooting of formulations/products in term of composition (formulation) and process (method of manufacturing).
Support all the above mentioned cross functional activities to team Scientist for the projects allocated to them.
6. Projects management
Preparation of product development strategy and day-to-day timeline updation of projects allocated to him and his Team.
Candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements.
Interested candidates may also email their resume to career@unisonpharmaceuticals.com
إرسال تعليق