1.
Job title : Manager
Business Group / Business Unit /
Service Unit : Siddharth Carbochem Products Ltd
Department : Quality Control
Location : Jalgaon
2.
Place Organization Structure
Reports to : Plant Head
Direct reports : Plant Head
Indirect reports : Director
3.
- Making of new design, layout and approval of new laboratory and related project works.
- Monitoring and Review of Sampling & testing of raw materials, packing material, bulk products, finished products & stability samples and review of analytical reports of same.
- Responsible for Release / Rejection of Raw material, Packing Material, Intermediates and Finished Products.
- To conduct Qualification Audits for Contract Testing Laboratory.
- To conduct vendor audits and responsible for vendor qualification and approval.
- Review of Technical agreements and Quality agreements.
- To conduct internal audits and to implement corrective and preventive actions.
- Represent Quality Control Department in Regulatory and Customer Audits.
- To train the team in analytical laboratory practices and provides support to team.
- Provide GLP and on job trainings to new joinee in Quality Control Department.
- Review of annual training schedules, training modules and cGMP and GLP trainings.
- Review of specifications, analytical work records, general test procures, analytical reports, test methods, working standard records, analysis trend reports.
- Approval of Certificate of Analysis for Raw Materials and Packaging Materials.
- Review of Certificate of Analysis for Semi-Finished Product and Finished Product.
- Responsible for periodic review, updation and improvements in current SOPs and quality system.
- Review of Quality manual, Site master file and Validation master plan.
- To perform/ participate in Investigation and Root Cause Analysis of customer complaints, Laboratory Incidences/ OOS/ OOT/ Deviations in Quality Control Lab and Cross-functional departments and, suggest appropriate Corrective Action and Preventive Action. Review the Investigation Report.
- To review the Change Controls initiated and Quality Control department and of cross-functional departments.
- Review the Protocol and Reports of experimental study, analytical method validation/ verification/ transfer, stability study and other miscellaneous protocol and report.
- Responsible for Analytical method validation, Method verification, Revalidation and Analytical method transfer activities.
- Responsible for inventory management including equipment/ instruments selection, procurement and budget forecasting.
- Responsible for recruitment of QC staff.
- Compiling and producing the data of Quality Metrics and & statistics on a daily, weekly & monthly basis to Top Management and presenting during Quality Review Meeting.
- Preparation maintenance of laboratory standards/reagents, Storage of control samples.
- Conducting literature search on compounds of interest to identify suitable methods & any associated impurities/ degradation products/related substances
- Monitoring and Review of Validation of analytical methods for QC release testing of active ingredients, intermediates, & finished products.
- Monitoring of operation, calibration & maintenance of lab instruments/ equipments and records of same.
- Handle qualification of new laboratory instrument/ equipment in the Quality Control lab.
- Approval of AMC, PM and Calibration schedules.
- Monitoring regular stability study samples and documentation.
- Ensure strict compliance of GMP/GLP guidelines in all areas of Quality Control Lab.
- Conduct and monitory Analyst Qualification activity.
- Overall responsibility of Quality control department
- Adheres to safety rules and awareness, demonstrates good safety practices in Quality Control Department at all times. Takes initiative to report and correct safety hazards/ near misses.
- Self-Aware of use of Personal Protective Equipment (PPE) associated with assigned task and educate the team about awareness and use of PPEs.
- Any other work assigned by Reporting Head.
4.
4.1 University education- M.Sc. Organic Chemistry or equivalent.
4.2 Excellent spoken, understanding & written English language skills.
4.3 Should have proficiency in MS Office applications.
5.
5.1 More than 20 Years in Chemical industry/ Pharmaceutical Industry in Quality Control Department.
5.2 Good communication & interpersonal skills.
6.
Supervisor : Director
1.
Job title : Manager
Business Group / Business Unit /
Service Unit : Siddharth Carbochem Products Ltd
Department : Quality Control
Location : Jalgaon
2.
Place Organization Structure
Reports to : Director
Direct reports : Director
Indirect reports :
3.
- Making of new design, layout and approval of new laboratory and related project works.
- Monitoring and Review of Sampling & testing of raw materials, packing material, bulk products, finished products & stability samples and review of analytical reports of same.
- Responsible for Release / Rejection of Raw material, Packing Material, Intermediates and Finished Products.
- To conduct Qualification Audits for Contract Testing Laboratory.
- To conduct vendor audits and responsible for vendor qualification and approval.
- Review of Technical agreements and Quality agreements.
- To conduct internal audits and to implement corrective and preventive actions.
- Represent Quality Control Department in Regulatory and Customer Audits.
- To train the team in analytical laboratory practices and provides support to team.
- Provide GLP and on job trainings to new joinee in Quality Control Department.
- Review of annual training schedules, training modules and cGMP and GLP trainings.
- Review of specifications, analytical work records, general test procures, analytical reports, test methods, working standard records, analysis trend reports.
- Approval of Certificate of Analysis for Raw Materials and Packaging Materials.
- Review of Certificate of Analysis for Semi-Finished Product and Finished Product.
- Responsible for periodic review, updation and improvements in current SOPs and quality system.
- Review of Quality manual, Site master file and Validation master plan.
- To perform/ participate in Investigation and Root Cause Analysis of customer complaints, Laboratory Incidences/ OOS/ OOT/ Deviations in Quality Control Lab and Cross-functional departments and, suggest appropriate Corrective Action and Preventive Action. Review the Investigation Report.
- To review the Change Controls initiated and Quality Control department and of cross-functional departments.
- Review the Protocol and Reports of experimental study, analytical method validation/ verification/ transfer, stability study and other miscellaneous protocol and report.
- Responsible for Analytical method validation, Method verification, Revalidation and Analytical method transfer activities.
- Responsible for inventory management including equipment/ instruments selection, procurement and budget forecasting.
- Responsible for recruitment of QC staff.
- Compiling and producing the data of Quality Metrics and & statistics on a daily, weekly & monthly basis to Top Management and presenting during Quality Review Meeting.
- Preparation maintenance of laboratory standards/reagents, Storage of control samples.
- Conducting literature search on compounds of interest to identify suitable methods & any associated impurities/ degradation products/related substances
- Monitoring and Review of Validation of analytical methods for QC release testing of active ingredients, intermediates, & finished products.
- Monitoring of operation, calibration & maintenance of lab instruments/ equipments and records of same.
- Handle qualification of new laboratory instrument/ equipment in the Quality Control lab.
- Approval of AMC, PM and Calibration schedules.
- Monitoring regular stability study samples and documentation.
- Ensure strict compliance of GMP/GLP guidelines in all areas of Quality Control Lab.
- Conduct and monitory Analyst Qualification activity.
- Overall responsibility of Quality control department
- Adheres to safety rules and awareness, demonstrates good safety practices in Quality Control Department at all times. Takes initiative to report and correct safety hazards/ near misses.
- Self-Aware of use of Personal Protective Equipment (PPE) associated with assigned task and educate the team about awareness and use of PPEs.
- Any other work assigned by Reporting Head.
4.
4.1 University education- M.Sc. Organic Chemistry or equivalent.
4.2 Excellent spoken, understanding & written English language skills.
4.3 Should have proficiency in MS Office applications.
5.
5.1 More than 20 Years in Chemical industry/ Pharmaceutical Industry in Quality Control Department.
5.2 Good communication & interpersonal skills.
6.
Supervisor : Plant Head
