Assoc, Quality Q & V
Baxter International · Ahmedabad · onsite · Posted 64d ago
Not disclosedFresherfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification.
- To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Supervisor regarding any non-conformity from planning and execution.
- To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Supervisor and approved by Manager.
- To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Trackwise.
- To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date.
- To ensure samples withdrawal during process validation & keep Supervisor updated about any non-conformity.
- To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents.
- To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by Supervisor.
- To attend trainings of each protocol before execution of any validation and qualification activity.
- To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA.
- To update the protocols as per current regulatory requirement to improve the validation documents.
- To prepare VMP as per regulatory guideline or any audit compliance requirement and provide it to Supervisor for review & approve.
- To keep the validation document updated from GMP aspect as per regulatory expectation.
- Planning and execution of validation activities associated with QMS elements.
- To inform the activity or issues which might occurred during the shifts validation activities through daily meeting.
Sourced from foundit
Skills
corrective and preventive actionQMSQuality AssuranceQuality Control
About Baxter International
Baxter International
Healthcare
5k+
employees
1931
95 years old
Kolkata, West Bengal
India
₹20.4L PA avg
Avg at Baxter International
About
Baxter hires a range of talented and driven individuals with diverse skill sets and backgrounds, from scientists and researchers to industry professionals in manufacturing, engineering and technology,
Industries
HealthcareMedical EquipmentPharma
Employee ratings
10 reviews
3.8/ 5
Culture
3.9
Career growth
2.1
Work-life
3.5
Employees rate it well for
Work-Life Balance40Company Culture38
Find them on