Karishma Kaur

QA/QC Specialist, *PQM

Seeking an opportunity in pharmaceutical industry wherein I can utilize my 10+ years of experience along with an extensive knowledge in quality assurance, quality control and resource management to mutually grow with the company.

Experience

Education

April 2023 - Current

QA Specialist, 3PQM Boehringer-Ingelheim, Remote

Works independently to provide QA oversight and support for Contract Partners (Manufacturing Organizations (CMO), Laboratory Organizations (CLO)) and other partners as assigned.

Responsible for day-to-day oversight and management of Contract Partners throughout the contract life-cycle for all Quality and Compliance topics.

Ensure Contract Partners adhere to procedures and agreements, change management, deviation management, CAPA plans, risk management, and Annual Product/Quality Reports.

Support qualifications of new Contract Partners, the expansion/ maintenance of services provided to Contract Partners, and periodic evaluations of Contract Partners in line with qualification plans, QAA, procedures and applicable regulations.

Support audits & inspections by participating in inspection readiness activities and in inspections by regulatory agencies.

Support regulatory submissions as related to Contract Partners.

Serve as a Subject Matter Expert for internal matters related to contracted activities.

February 2021 – March 2023

QA Master Associate Boehringer-Ingelheim, Fremont CA

Monitor and recognize areas for improvement of 3PQM relations.

Drive changes through quality systems and during regular reviews of CMO/CLO.

Master of Science, Biochemistry

California State University, East Bay

Hayward, California

Bachelor of Science, Biochemistry (Minor Chemistry)

California State University, East Bay

Hayward, California

Skills

QA Oversight of CLO/CMO/CMB

Change Control Management

Deviation Management

Internal, FDA and Client Audits/Inspections

Outstanding Communication

Problem-solving

Teamwork

Contact

Frisco, TX

925-***-****

ad3dvb@r.postjobfree.com

Experience Cont.

Support onboarding and qualification of new CLO and revisions to services provided by existing/qualified CLOs. Support development of contractors (CMO/CLO).

Attend project team meetings to support QA guidance and oversight to such improvements and support internal or external audits/inspections.

Support Quality System topics such as deviations, CAPA Plans, and change controls with their potential impact.

Responsible for coordinating tasks associated with quality oversight of the change management system. This includes verifying changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues.

Ensure all specifications are met and that applicable requirements are completed and acceptable.

Provide continuous improvement ideas in the assigned area to recognize opportunities for improvement and drive the change through the use of company’s Quality Systems.

August 2019 – February 2021

QA Senior Associate Boehringer-Ingelheim, Fremont CA

Responsible for executing strategic operations required to assess, evaluate, and review against cGMPs to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation.

Provide guidance for assigned area to ensure compliance with all applicable regulations and SOPs and assist in resolution of issues identified.

Support execution of remediation/CAPA activities required to continue operations or move a process to the next milestone.

Support investigation team to identify root cause and potential preventative/corrective actions for the timely closure of investigations.

Escalate critical issues to the senior management team based on severity of the issue.

Perform technical review of documentation during and post-execution of cGMP activities.

Ensure all issues/documentation associated with each process in assigned area have been resolved prior to submitting to the next step for Approval and Release and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.

June 2014 – August 2018

QC/QA Analyst II Impax Laboratories Inc., Hayward CA

Performed analysis of finished products, raw materials, in-process and cleaning validation using analytical instruments and established analytical procedures and techniques as scheduled and by set deadlines.

Reviewed laboratory documents (notebooks/worksheets) to ensure they are accurate and complete, and that the work performed is in compliance with current procedures, and analytical methods.

Wrote, reviewed and executed protocols for method validations development, performance operational qualification, training documents, SOP’s and other technical projects.

Excellent skills in dissolution and disintegration testing with compliance required within SOP, cGMP, GLP and FDA regulatory environments.

Worked with management to analyze OOS/OOT and LIR investigations for completing CAPA’s.

Maintained, operated and troubleshoot HPLC’s. Performed general maintenance and calibration of laboratory equipment.

Interviewed and trained new analysts where appropriate within the QC laboratory.

Supported a culture of “quality” in the laboratory environment by modeling behaviors that demonstrate and support continuous quality improvement.

Independently performed or monitored 5S and CI related tasks.

January 2011 – August 2014

Lab Technician II The National Food Labs, Livermore CA

Performed routine analyses and procedures such as Salt, pH, Titratable Acidity, Moisture analyses.

Prepared and extracted samples for Fat, Sugar and Vitamin extractions and prepared standards for several HPLC assays.

Produced accurate, traceable, and defendable results on time and ISO 17025 and GLP conditions.

Maintained basic equipment so that they are in good working order along with a safe and clean laboratory environment per 5S.

Followed appropriate SOPs, analytical methods, and protocols.

Supervised and trained technician as directed by division manager.

Worked as a team with all staff to accomplish position and business objectives.

Technical Skills

•CLO/CMO Oversight

•CMB QA Contact

•FDA Audits

•Internal Audits

•Client Audits

•PAIs

•QAAs/MSAs

•Intercompany QAAs

•Participation Agreements

•Quality Agreement Negotiations

•Deviation/CAPA Management

•Change Management

•Veeva/SAP/TrackWise

• FDA Regulations

•QC Analyses

•Discrepancy Risk Assessments

•KPI/Metric Management

•MS Office Suite

•Outstanding communication

•Time Management

•SharePoint

•Continuous Process Improvement

•Gap/Impact Analysis

•Process Flow Diagrams

•QA SPoC

•Harmonizing procedures

•Global Relations

•APR/PQR

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