Website Zydus Group Ltd
Post Name: QA Chemist (IPQA)
Division: Moraiya
Department: QA
Category: Staff
Qualification: B.Pharma/M.Pharma
Experience: 3 – 8 Years
Zydus Experience: Must have completed at least two PMS cycle.
Job Responsibilities:
· Monitor the manufacturing processes to ensure that the drug product is manufactured as per procedure mentioned in respective Batch Record and SOP with proper documentation.
· Proper planning of available manpower to ensure that there is no manufacturing process loss or delay.
· Ensure that Line clearance of area, equipment and instruments is carried out competently.
· Ensure that the product is manufactured as per defined specifications.
· Ensure collection of in process samples, finished product sample, QP sample, Stability sample and any other samples as per approved sampling protocol and SOP.
· Monitor Hold Time study and Swab sampling as per approved protocol and SOP.
· To ensure proper handling and correct usage of respective process materials.
· Review/approve master batch records, SOPs, protocols, reports, risk assessment, self-inspection reports and other applicable documents.
· Review/verify/approve all the relevant documents as per procedure defined in respective SOPs.
· To ensure proper recording of necessary data, including process parameters and test results.
· To ensure proper handling of the in-process rejections, batch rejections and scrap as per SOP.
· Perform the Batch Release Activity for Exhibit and commercial Batches.
· To perform periodic inspections of the manufacturing areas, equipment, and facilities to identify and address any non-compliance issues.
· To escalate the issues related to the Process, Product, Quality, Cleaning or documentation related activities to immediate superior and take appropriate action related to it.
· To escalate any failures and overdue activity that can have a potential impact on product quality to immediate reporting authority.
· Ensure collection of RFT data and trending of the same.
· To Participate/facilitate cross-functional investigations.
· To ensure and impart training of SOPs and other necessary trainings to all concern personnel.
· To represent in the internal/ external Audits and to participate in the self-inspection activities.
· Responsible for initiation and review of Investigation reports pertains to deviations, Out of specifications, Out of trend and others if any.
· Responsible for initiation, review of change controls, CAPA and ensuring completion of action items.
· Perform SAP transactions as per requirement.
· Ensure Current Good Manufacturing Practices (cGMP) are followed in the facility.
· Report accidents and unsafe conditions or unusual circumstances to reporting manager.
· Other duties, which may be assigned from time to time, by reporting manager.
Essential job requirements:
· Understand the purpose and function of the respective area, equipment and operations.
· Co-ordination with Subordinates and other departments.
· Knowledge of statistical data analysis techniques and their application.
· Understands the Good Documentation Practices, ALCOA policy.
· Strong attention to detail and ability to identify discrepancies, deviations, and non-conformances
· Problem solving Skills.
· Ability to make timely and well-informed decisions.
· Comply with the Privilege rights matrix (PRM) of the Organization.
