Assistant Manager / Manager - Quality Control

Job Description:

Job Description:
1. Analysis
1.1  Raw material / packing material analysis at the time of incoming
1.2  In process analysis time to time
1.3  Finished product analysis and compare to require specification compliance
2. Manage QC lab
2.1  Method validation – Set test methods as pharmacopoeia and GMP requirement.
2.2  Instrument calibration: Prepare calibration Schedule and calibration as per schedule.
2.3  Properly execute actual testing done as per SOP.
2.4  Manpower arrangement and set shift setting as per shift Schedule.
3. Training
3.1  Prepare training schedule with help of HR Department.
3.2  Well inform to related department in 2 days prior through mail and by phone.
3.3  Provide training as per schedule.
3.4  Training effectiveness and re train if require.
4. Trend Analysis
4.1  Trend analysis of basic raw material.
4.2  Finished product trend for all tests.
4.3  Water analysis tends.
4.4  Investigation for out of trend if found.
5. Batch release: Review analysis report and release hold the batch if any non- conforming found
5.1 Report to Quality Assurance and follow the instruction.
5.2 If required jointly challenge test to be conducted
6. To get pharmacopoeia monographs of latest edition within 2 months after launch the Edition
6.1 Which is informed to QA and required paper work /deviation & Change control activities need to perform.
6.2 Training to the down the line staff to be performed with the help and the direction of the Quality Assurance Manager.
7. Authorities
You are authorized to carry out following jobs.
7.1 To approve or reject leave, overtime early going and late coming of all your subordinates.
7.2 To allocate and carry out RM/PM/ON line analysis and pass or reject the same if quality doesn’t matches as per the requirements.
7.3 To prepare and implement Quality Policy in consultant with senior management.
7.4 On receipt of any customer complain will be responsible to prepare CAPA after investigation.
7.5 Maintain the QC Lab and effective usage of lab Instruments, calibration process Validation & analytical testing related activity with MIS and cGLP practices.
7.6 Prepare daily MIS and Monthly MIS.
7.7 Management will have all rights to change location, timing, job responsibility, salary structure as per the manual understanding of Higher Authorities without any prior intimation.