Quality Control Manager

Dear Candidates,

We are looking for Manager/Sr Manager Quality Control for our plant at Jalgaon Location

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 the control on 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.Ensure strict

compliance of GMP/GLP guidelines in all areas of Quality Control Lab.

 Overall responsibility of Quality control department and knowledge of IMS and objectives.

 Adheres to safety rules and awareness, demonstrates good safety practices at all times. Takes

initiative to report and correct safety hazards. Uses Personal Protective Equipment (PPE)

associated with assigned task.

 Should be expert into 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 reportsTo check the documentation of all test

results of RM & FG.

 Preparation of SOP and Work instructions.

 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.

 Knowledge ofTo 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 Preparation of 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. Monitors laboratory resources, identifies/reports resource gaps, and

assists in recruiting, screening, procuring, and qualifying needed resources

 Responsible for recruitment of QC staff.

 Compiling and Producing the data of Quality Metrics and regular reports & 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.

 Writing method, method validation reports, test methods & related SOP’s.

 Sampling & testing of raw materials, bulk products, finished products & stability samples.

 Monitoring of Operation, calibration & maintenance of lab instruments/ equipment's and records

of same including, but not limited to analytical balances, PH meter, GC, KF titrator, Viscometer,

charge analyzer ovens, sieve analysis.

 Checking & verification of analytical result generated by lab analyst, executives.

 Maintenance & calibration of laboratory equipment. Documenting work activities timely and

accurately in an organized manner.

 Monitors laboratory resources, identifies/reports resource gaps, and assists in recruiting,

screening, procuring, and qualifying needed resources. 

 Internal Quality Audit and external auditor for vendors with reference to GMP's.

 Handle compliance activities and qualification of all instruments new laboratory instrument/

equipment in the Quality Control lab.

 Approval of AMC, PM and Calibration schedules.

 To maintain safety precaution in laboratory and giving GLP training to new joined

 Monitoring regular stability study samples and documentation.

 Review of analytical reports 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