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5 Bioaltus Laboratories Jobs
HOD / Manager / QA - QC / API .
Bioaltus Laboratories
posted 4mon ago
Job Role Insights
Key skills for the job
Job Description
Experience: Minimum 8-10 years
Education: M.Sc Analytical Chemistry
Job Responsibility
Analysis:
- Raw material / packing material / solvents analysis at the time of incoming
- In process analysis.
- Finished product analysis and compare to require specification compliance
Manage QC lab
- Method validation Set test methods as pharmacopoeia and GMP requirement.
- Instrument calibration: Prepare calibration Schedule and calibration as per schedule.
- Properly execute actual testing done as per SOP.
- Manpower arrangement and set shift setting as per shift Schedule.
Training*
- Prepare training schedule with help of HR Department.
- Well inform to related department in 2 days prior through mail and by phone.
- Provide training as per schedule.
- Training effectiveness and re train if require.
Trend Analysis
- Trend analysis of basic raw material.
- Finished product trend for all tests.
- Water analysis tends.
- Investigation for out of trend if found.
Batch release:
- Review analysis report and release hold the batch if any non-conforming found.
To get pharmacopoeia monographs of latest edition within 2 months after launch the Edition Authorities
QA/QC Manager will be authorised to:
- To allocate and carry out RM/PM/Online analysis and pass or reject the same if quality doesn t matches as per the requirements.
- To prepare and implement Quality Policy in consultant with senior management.
- On receipt of any customer complain will be responsible to prepare CAPA after investigation.
- Maintain the QC Lab and effective usage of lab Instruments, calibration process Validation & analytical testing related activity with MIS and cGLP practices.
- Prepare daily MIS and Monthly MIS.
QC activities as below,
- Prepare specification for analysis
- Hold time study
- Microbiological sample collection and monitoring of fumigation activity.
- Suggest and provide guidance to the shop floor if microbiological counts are increased.
Other Responsibilities:
- Responsible for Documentation work in QC & QA Department
- Responsible for manufacturing the batch as per MOM or BMR.
- Shall maintained all records related to manufacturing
- To ensure the compliance of safety Requirement, Cleanliness Hygiene and Environment in Working Areas.
- Responsible for Domestic / Export/ batch production & their Documents for their smooth Dispatch Activity.
Employment Type: Full Time, Permanent
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