Hrishikesh Tendulkar
Quality Assurance Executive
About
P&G ESS QA Responsibilities
* Working with site as per global 3M requirement and give technical clearance to strategic CM i.e., Softech and Unique Daman.
* Performing Health check assessment at ESS sites and identifying the gap prior to Audits.
* Highlight to site Critical / Major observation of health check to the management.
* Allocate CAPA and completing the compliance of all Health check observations on site before the final Audit Assessment.
* Real time assessment status updating in Veeva- MSR & QATA as applicable.
* 100% compliance to ESS sites, planned visits according to calendar for verification on all the cGMP/Product compliance requirements.
* Executing DI training to CM sites before Audit Assessment
* Ensure ESS site shall demonstrate P&G system & regulatory compliance during CQA assessment so
that overall site risk level to be maintained No critical observation and site shall be target as Low &
Medium risk to Business Operations and Quality Aspects.
* Audit CAPA completion on time as per P&G requirement. 100% quality oversight ESS sites, QATA
Compliance & Scorecard review with ESS site.
* Review of online manufacturing and analytical data sheet along with FP COA of each batch prior to release to market (LL {Loan License} sites). After assessment if there was any discrepancy observed routed though appropriate QMS system.
* 100% assessment of CM sites changes/deviation and OOS/OOT/OOC, critical/repeat complaints as per P&G policies, procedure, and regulatory requirements.
* Need based training shall be imparted to CM sites for uplifting quality of product as per requirement.
* Approach ESS site for continuous improvements to ensure GxP level of compliance.
* 100 % compliance Investigation of Market complaints of ESS sites along with root cause identification and defined CAPA as per defined timeline as per P&G SOP.
* Review of CAPA implementation and its effectiveness check within planned timeframe.
* Real time assessment status updating in change control, QSF review of Veeva - MSR
* Implementation of 3M solution with appropriate ensuring validation, SOP preparation, PI & BPR control and initiating appropriate QMS documents as per defined timeline.
* To perform risk assessment of high/critical risk sites and establish mitigation plan and ensure GMP compliance.
* Update the MSR as and when required with most recent information from site including external audit, BOH visits, customer audit details.
Previously working with Johnson and Johnson for Regional Quality Systems and Performance Team for IT Quality Systems
Contact Information
Professional Email
****@****.com
Personal Email
ris****@gmail.com
Work Phone
(982) 044*****
Mobile
(982) 044*****
Local Location
Thane, Maharashtra, India
Industry
Retail Health and Personal Care Products
Designation
Quality Assurance Executive
Birthday
March 5
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