About the Company
About the Job
JOB DESCRIPTION: MANAGER QUALITY CONTROL
Location of the Job : AMBERNATH
REQUIREMENT:
Candidate required to have MSC Chemistry with About 20 years of experience with API manufacturing and about 5 years of experience working at senior position.
Self-directed and motivated with minimal supervision. Strong ability to work and communicate with the team. Exceptional capacity of managing simultaneous activities and challenges and guide to all team members.
Strong oral and written communication skills and effective interpersonal skills.
Must be team oriented and a decision-maker.
Strong organizational skill with effective time management ability.
Fully conversant with all guidelines related to API and provide all regulatory and customer queries response received from authorities and marketing related to process and analytical.
Strong problem-solving skills and aptitude for learning existing systems quickly and adopt new system to improve the efficiency of API division.
Overall monitoring of functioning of the Quality control laboratory.
Ensure that the laboratory is being operated in continuous compliance mode.
Participate in the OOS / OOT investigations and ensure that root cause is identified.
Investigation of laboratory incidents and deviations. External communication with various departments and customers
Documentary support to Regulatory filing requirements
Ensure Timely release of the Raw material, in-process, intermediate and Finished products batches in order to meet the production timelines and company goals.
Ensure that all the key analytical methods used for testing of Keys starting material, intermediate, Equipment cleaning samples, in-process and API are validated
Monitoring of stability study batches and ensure timely completion of analysis as per schedule.
Maintaining of the data integrity in the quality control laboratory.
Imparting Training to all the QC staff.
Preparation and review of the SOPs related to quality control laboratory such as general SOPs, Operation and calibration SOPs of QC equipment.
Monitoring and ensuring that all the QC equipment are timely calibrated/ validated as per schedule.
Participate in process validation and cleaning validation of new products and existing products.
Trouble shooting of the problems in QC.
Development of second line in QC department for smooth functioning.
Ensure that all equipment/ instrument softwares are validated.
send resumes to [email protected]