About the Company :
About the Job :
We have an #urgent requirement from #Syngeneinternationalltd at #Mangalore Location.
Department: Microbiology
Designation: Executive
Qualification: MSc. in Microbiology
Experience: 3 - 4 years years of experience
Required Skills:
• Media preparation and sterilization, Sample receipt and register the sample.
• Sampling and Labelling of Raw Material/ Packing Material/ In process/ Intermediate/ Finished product as applicable. Preparation of environment, water, product trends.
• Microbial environmental monitoring in microbiology and manufacturing plant clean rooms, utility sampling and testing like nitrogen and compressed air sampling and related documentation
• Microbiological testing for raw materials, in-process samples, intermediate samples finish product for bioburden/MLT and related documentation
• To track the Purchase Requisition in SAP and to follow up with regard to purchase order, to track Inventory management and purchase coordination for various material requirements for microbiology lab
If Interested, please share your resume to [email protected]
Sun Pharma - Manager investigations:
Location: Halol
JD:
To manage the following QMS activities: Market complaint investigations, Out of specification (OOS), Out of trend (OOT), and Unplanned Deviation (UPD).
To get feedback from other departments involved in the investigation process and deviation conclusion so that the Oral Solid department's investigation reports can be closed on schedule.
Immediate Brainstorming to identify additional steps and their intended completion dates (TCD).
to keep track of cross-functional investigations that need to be done with TCD and the best course of action.
If the investigation's root cause cannot be found, the investigation should be escalated to site quality leadership.
to take part in weekly block head meetings and biweekly site leadership team meetings to discuss how to go forward with open cross-functional probes.
in order to take part in the site investigation review
To attend meetings of the Site Investigation Review Board:
to offer information on ongoing and completed investigations.
To examine the problem, the information in the report, the suitability of the root cause that has been found, and to evaluate the choice of product and material disposal.
to examine the patterns in deviations and findings in order to make further improvements in routine management review sessions.
the shop floor team should be instructed on reported deviation, investigation, and suggested CAPA to prevent recurrence.
accountable for completing CAPA and associated tasks in the Trackwise system on time.
Using product CQA trends to identify early trends that may be altering or drifting With the help of a cross-functional team, corrective action is started based on an understanding of the pattern.
Utilizing cross-functional teams to discover any recurrent failures with a similar cause or product by trending batch rejects.
Document preparation and review as follows:
Reports on unanticipated deviations, investigations, addendums, compliance, and closing.
CAPA effectiveness check reports and CAPA plans.
Reports & Protocols.
Compliance and closure for internal and regulatory quality audits.
cGMP documentation, including but not restricted to,
Sequential Log, Checklist, Labels, Instrument Inward-Deletion Slips, In-Process / Finished Product Test Requisitions, Data Reports, Bulk Quarantine / Staging room In-Out Records, etc.
Standard Operating Procedure, change management.
Amendments to other high-quality texts.
Make regular reports to superiors on the department's daily activity.
coordination of relevant activities with other departments like administration, warehouse, quality assurance, quality engineering, MIS, and engineering.