WE'RE HIRING
Exemed is regulatory compliant, Customer-centric, and global leading pharmaceutical company in India It is supported by two manufacturing facilities involved in the manufacturing of Drug-intermediates and specialty chemicals. Our state-of-the-art US FDA, EDQM, EU GMP certified facility is located in Luna & Yapi and headquartered in Vadodara, Gujarat.
Position-Qualification-Job Description
Experience
*To issue, review and closure of Quality Management System.
To prepare Annual Product Quality Review.
*Review Equipment and Instrument Qualification, proper document correction and writing procedure. To ensure the Market complaint investigation and implementation of Corrective Actions.
Return and Recall of material and also for the Mock Recall activity. •Approve or reject intermediate, Bulk and finished product.
"Preparation and review of Site Master File & Validation Master Plan & preparation of Organogram of personnel in the department.
QA Executive Having Qualification
•Self-Inspection and compliance of audit observations.
8.5c/M.Sc. Organic Chemistry Experence:
8 to 10 Years Exp. in API Industries
*Conduct training on cGMP, SOP's and on job training.
"Monitor & ensure the sampling, labelling and sealing activity as per SOP, look after the plant housekeeping. •Review temperature mapping protocol and report, vendor qualification and to conduct vendor audit.
To review SOP's, specifications, STP's, GTP's, Process Validation, and Cleaning Validation. To review Batch Manufacturing Record, Batch Processing Record, Equipment Cleaning Record, Process Development Report.
*Responsible for the regulatory and customer correspondence.
*Responsible for the issuance, distribution and retrieval of SOP's and log books & plant round according to GMP. *Responsible for preparation of stability study protocol, to charge samples in stability chamber and withdraw the samples as per the
schedule of analysis, to ensure that the samples are charged in stability as per the SOP, preparation of stability analysis summery report, daily monitoring of the stability chamber, ensuring daily backup of the stability data.
Other activities as instructed by the Head QA.
Address: Block No.628 (A & B) ECP Canal Road, Village- Luna, Taluka
0 Comments