General Manager - Quality Control

Job Description:

 Quality Control department functions for assuring the quality of all the batches manufactured,
at every stage of manufacturing/processing excipients and drug products.
 Sampling, inspection & testing as per specifications of Raw material for release or rejection
& its documentation.
 Sampling, inspection & testing as per specifications of packaging material for release or
rejection & its documentation.
 Sampling, inspection & testing as per specifications of in-process product for release or
rejection for further processing or reprocessing & its documentation.
 Sampling, inspection & testing as per specifications of finished products for release or
rejection for further processing or re-processing & its documentation.
 Release or rejection of every batch of Drug Products for distribution and sale.
 Stability chamber handling, Stability testing and evaluation of shelf-life of products as per
the stability interval planner.
 To prepare or review of stability testing protocol and report and summary report.
 Microbiological analysis of raw material, finished products, water and environmental bio-
burden monitoring.
 To review of monthly trend prepared for physicochemical and microbiological trend data
and it’s complying with the predefined specifications.
 Analytical investigation for complaints and product recalls.
 Analytical support for evaluating the Change Control proposals & Systems.
 Out of specification investigations for laboratory results.
 Investigation of deviations in the analysis.
 Analysis of Returned products (salvage and disposal).
 Internal Quality System Audits and Quality Review.
 Analysis for Control of non-conforming products.
 Reference standards, working standards, solution preparations.
 To plan and manage all the activities of the Quality Control Department To assure the
quality of all products manufactured by the Company.
 To co-ordinate with manufacturing department in controlling their process and products at
every stage of manufacturing to meet the established specifications through testing, auditing
and reporting.
 To co-ordinate for development of specifications, the analytical procedure in coordination
with Quality Assurance Department and R&D.
 To review the adequacy and relevance of specifications & analytical procedures in
coordination with the Quality Assurance Department and R&D.
 To be responsible for instruments qualification as per the guideline and prepare protocols

and reports accordingly.
 To ensure that audit trail system are implemented including systems for data integrity and
data security.
 To co-ordinate technical audits of the Quality Control Laboratory to determine the analytical
Quality Systems are yielding the highest quality information and to ensure that the
analytical instrumentation is functioning properly and calibration and servicing is as per
schedule.
 To be responsible for glassware cleaning protocol and report, also establish of cleaning
procedures.
 To be responsible for the Quality Control functions and records, which shall include:
 Maintenance of Quality Control records, Control samples of raw materials and drug
products/excipient each batch manufactured.
 Records of release, quarantine or rejection of components and finished products, containers,
closures and labels based on Quality Control test results.
 Routine “Good Laboratory Practices Auditing" of the control process, and related areas.
 To suggest and organize training programs for the development of technical and
administrative skills of all the employees to meet with cGLP regulations on the continuous
basis, which shall be done by co-ordination with Plant and Quality Heads.
 To establish guidelines and procedures on cGMP and Good Laboratory Practice — Standard
Operating Procedures of overall Quality Control Activities. Protocols related to Method /
Process/ Cleaning/ Analytical Method Validation etc.
 To evaluate the Change Control suggestions for overall reviews of non-conformances,
failure investigations, analyzing the Quality trends, investigations of market complaints,
batch failure investigations, deviations, verifications of change control procedures, updating
the specifications, test procedures, manufacturing processes etc.
 Validation of analytical test procedures, specifications, standard operating procedures (both
pharmacopeial and In-house).
 To follow the reporting system as per the company procedure.