QA Manager

Karishma Kaur

925-***-**** **********@*****.***

Frisco, TX 75033 https://www.linkedin.com/in/karishmakaurqaexpert/

Summary

Dedicated Quality Assurance Manager with over 10 years of experience in the pharmaceutical and laboratory industries. Proven expertise in managing quality systems, supporting comprehensive audits, and driving continuous improvement initiatives with relevant regulations. Adept at collaborating with cross-functional teams to ensure compliance and enhance operational efficiency. Experienced in mentoring and training junior staff, with a strong focus on maintaining high standards of quality and patient safety. Seeking to leverage my extensive background in quality assurance to contribute to the continuous improvement of supplier and service provider quality systems within a dynamic organization. Currently, working towards acquiring an ASQ certification.

Future Ambitions:

Leadership Development: Aspire to take on more leadership roles, guiding and mentoring junior auditors and quality professionals.

Specialization in BioPharma: Aim to deepen expertise in BioPharma processing activities and API manufacturing.

Global Quality Management: Interested in expanding my role to include global quality management responsibilities, working with international partners to drive quality improvements across diverse regions.

Innovation in Quality Systems: Passionate about implementing innovative quality systems and methodologies to enhance operational efficiency and compliance.

Professional Experience

QA Manager

Boehringer-Ingelheim

April 2023 – Current

Provided QA oversight for Third Parties including CMOs and CLOs.

Interface with clients to ensure seamless compliance integration into the local quality systems for production needs

Directed day-to-day performance of Third Parties, ensuring quality and compliance throughout the drug manufacturing life cycle including regulatory topics by participating in weekly meetings, facilitating proactive solutions and driving quality metrics on quarterly basis

Key member in supporting local audits & inspections, supporting cross-functional teams and overseeing follow-up actions to assess quality concerns and develop strategies to mitigate associated risks, if needed implement CAPA's

Worked with suppliers to drive quality and compliance improvements stemming from audit outcomes.

Served as Subject Matter Expert for internal matters related to contracted activities such as negotiating Quality Agreements, providing QA support for investigations, QA contact for audit related concerns.

Optimized quality systems, reducing TAT by 30% for deviations and 10% for change controls.

Supported supplier qualifications, expansion/ maintenance of services provided to Contract Partners, periodic evaluations and monitoring applicable licenses under relevant regulations on a weekly basis

Conducted audits & inspections including performing inspection readiness activities and established audit reports (including internal, corporate, client, PAI, FDA)

Directed QA Release team to ensure each batch was market released in a timely manner with high quality standards which included overseeing finished product testing and report results, batch record review, verifying release documentation etc.

Reviewed regulatory documents such as IND, CTD, BLA including verifying regulatory submissions such as new changes being implemented at CMO

Delegated validation activities for a new product and processes at CMO

Influenced harmonized processes within global operations by leading projects and global communications

Created an all-in-one location for data management (incl. documents, agreements, procedures and a comprehensive guide for on-boarding purposes) per Quality Management System (QMS)

Motivated direct reports by providing positive feedback, development opportunities and ensuring the team is on track to meet performance goals.

QA Manager, 3PQM

Boehringer-Ingelheim

February 2021 – March 2023

Supported on-boarding and qualification of new CLOs.

Coordinated tasks associated with quality oversight of change management systems.

Monitored and recognized areas for improvement in 3PQM relations.

Delivered continuous improvement ideas and implemented them through Quality Systems.

Conducted audits for compliance with GMP and other relevant regulations.

Developed, reviewed and approved GxP controlled documents, such as: Policies, Standard Operating Procedures (SOPs), Work Instructions (WI), and supporting documents related to GxP activities

Master QA Associate

Boehringer-Ingelheim

August 2019 – February 2021

Executed strategic operations to ensure compliance with cGMPs.

Provided guidance for assigned areas to ensure regulatory compliance.

Supported execution of remediation/CAPA activities and investigation teams.

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

QC/QA Analyst II

Impax Laboratories

June 2014 – August 2018

Performed analysis of finished products, raw materials, and in-process validation.

Reviewed laboratory documents for accuracy and compliance.

Wrote, reviewed, and executed protocols for method validations and SOPs.

Acted as SME during implementation of Empower 3 software for HPLC use.

Lab Technician II

The National Food Laboratories

January 2011 – June 2014

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

Prepared and extracted samples for various assays.

Supervised and trained technicians as directed by division manager.

Education

Masters of Science, Biochemistry

California State University-East Bay

Bachelors of Science, Biochemistry

California State University-East Bay

Minor – Chemistry

Skills

Quality Assurance: QA Oversight of External Partners, Change Control Management, Deviation Management, NC/CAPA Management, Regulatory Inspections, CMO Audits, FDA Audits, Internal Audits, Client Audits, Pre-Audit Inspection.

Quality Management Systems: Quality Management Systems, 21CFR, ISO and ICH Standards, GMP/GDP/ISO, FDA Regulations, Third Party Quality Management, Collaborative Project Management, APR/PQR. Product Development Life-cycle.

Technical Skills: Veeva Vault, SAP, Track Wise, FMEA, QC Analyses, Gap Assessment, Risk Assessment, KPI/Metric Management, Regulatory Submissions, GxP Knowledge, Computer System Validation, API/Drug Substance Manufacturing, Drug Product Manufacturing.

Project Management: Project Management, Audit Coordination, Audit Reporting, Audit Preparation, Audit Response, Complaint Investigations, Trend Analyses, Operation Management, New Product Development (NPD), Process Development.

Methodologies: Six Sigma Methodology, 5S certified, Agile Methodologies.

Software: SharePoint, MS Office Suite.

Soft Skills: Attention to Detail, Team Leader, Outstanding Communication, Time Management, Relationship Building.

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