Urgent Hiring || Quality Control Head || Ankleshwar Gujarat Location ||

Location-Ankleshwar

POSITION: Quality Control Head

Experience-15 years

Ctc range-upto 16 lpa (depends on interview)

Working Days - 6 days

RESPONSIBILITIES:

- Responsible for technical management, supervision and control of quality control processes.
- Should be able to communicate with customers on matters related to disputes about testing.
- Assessing resources requirements for quality control function.
- Determining quality control standards.
- Making sure that all OOS instances are reported and evaluated and that OOS are investigated and the conclusions are recorded.
- Selecting, ordering and purchasing materials for QC setup.
- Ensures that QC and laboratory equipment is operating properly and is properly maintained.
- Manage and motivate QC staffs working under him to deliver exceptional work.
- QC Head will establish, document, and implement an effective system for managing quality of product.
- QC Head ensures that all quality related activities are defined and documented.
- QC Head will function independent of production and works closely with quality assurance (QA).
- QC Head is authorized to approve product after ensuring all requirements are fulfilled prior to approve.
- QC Head is responsible for all quality related activities are recorded at the time they are performed.
- QC Head will develop procedures for notifying responsible management in a timely manner of regulatory inspections, reliable GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.).
- Assists, directs, and supports QC / Laboratory personnel as needed. Provides suggestions for improved performances.
- The quality Head will review and approve all appropriate quality related documents.
- QC Head will establish a system to release or reject raw materials, intermediates, packaging and labeling materials.
- Watch for updates of monographs and pharmacopoeia documents.
- Assumes responsibility for ensuring that quality functions are conducted in accordance with certified quality standards, monographs and procedures.
- QC will make sure that all deviations are investigated and resolved.
- Ensures that QC Laboratory areas are clean, secure, and well maintained.




- QC will work with QA regarding approving contract manufacturers; approving changes that potentially impact product quality; reviewing and approving validation protocols and reports.
- QC Head will make sure that quality related complaints are investigated and resolved.
- Making sure that effective systems are used for maintaining and calibrating critical equipment.
- Making sure that materials are appropriately tested and the results are reported.
- Making sure that there is stability data to support retest or expiry dates and storage conditions on products where appropriate.
- Will work with QA on performing product Quality reviews.
- QC Head is responsible for monitoring stability study and retained sample management.
- Execution monitoring of duties of subordinates.
- Periodical review SOP related to QC functions and inform QA to incorporate revisions as justified due to latest technologies, developments.
- Maintain systems to detect usual wear and tear of QC utilities for effectively replacing in time to avoid QC stoppages.
- If QC equipment is computer controlled ensure necessary audit trail systems are implemented including systems for data integrity, data security and put in place required access control systems.
- Prepare appropriate training material for QC related areas.
- Should be able to adapt to changes in QC functions as per newer Quality requirements.
- Responsible for review or analysis as per existing release specification and test method.
- Responsible for review/preparation of relevant documents like reports of analysis, certificate of analysis and approved/ rejected label stickers.
- Responsible for review and approval of specification and STP.
- Responsible for review and check the records of volumetric solutions, reagents and stock solutions preparation records of standards as per sop.
- Responsible for Monitoring of calibration of equipments/instruments and keep updated records.
- Responsible for supervision of disposal of analyzed samples.
- Responsible for monitoring of housekeeping of laboratory.




- Responsible for participation or performing validation exercises pertaining to the department.
- Responsible for attending all training programs organized for chemists by company for continuous up gradation of knowledge for compliance with existing GMP/GLP guidelines and other relevant information.
- Responsible for complying with existing SOPs, relevant to all laboratory activities.
- Responsible for carrying out all activities in the laboratory such that it is in compliance with GMP/GLP/Safety guideline.
- Responsible for ensuring that analysis is done as per safety procedure and adequate safety measures.
- Responsible for maintaining discipline and following laid rules and regulations of the company.
- Responsible for analyst qualification activity and check and retrieve the reports.
- To check the testing of all incoming samples of Raw materials , packing material, in-process, water and update their records.
- To Maintain the stock of the all reagent in lab and send purchase request for new chemicals.
- Making sure that there is stability data to support retest or expiry dates and storage conditions on products where appropriate.
- Monitoring and verification of retained sample handling activity.
- To check and verification of all equipments and instruments of the laboratories.
- If QC equipment is computer controlled ensure necessary audit trail systems are implemented including systems for data integrity, data security and put in place required access control systems.
- QC Head will make sure that quality related complaints are investigated and resolved.
- Ensure that all reagents/chemicals, standard solution, volumetric solution etc. are labeled properly.
- Ensure that only properly labeled chemicals shall be allowed in the facility.
- Participate in Internal audit and make preparation of internal Audit.
- Maintain a Master chemical list is documented and audited annually.
- Ensure that used and or hazardous chemicals must be disposed of in compliance with applicable regulations.
- To investigate deviation/incident related to Environment management in coordination with concerned department head.
- To ensure that all decisions, rules and policies related to environmental management system is followed.
- To ensure that applicable legislations, regulations and other applicable requirements are met.

📌 Quality Control Lead (Gujarat)
🏢 orbit verify
📍 Gujarat