Krithika Krishnamurthy Email & Phone Number

Bengaluru, Karnataka, India

Result-driven QA Officer responsible for certifying batches manufactured for commercial distribution in the US, ROW, India, EU, and Canada. Proficient in performing quality oversight reviews, approvals, and facilitating final batch disposition, addressing quality issues, and coordinating the launch of new products. Skilled in ensuring compliance with regulatory standards through meticulous review and approval of documents and batch records for Qualified Person (QP) certification. I cultivate interdepartmental collaborations to address documentation challenges, ensure prompt and timely batch disposition. I also review and support third-party investigations and summarizing outcomes to the leadership team for closure. Trained in various software systems required for batch management – SAP, GLAMS, TrackWise and Documentum (D2, CARA). I have excellent attention to detail, effective communication, collaboration, and organizational skills, as well as my ability to work in a fast-paced, highly regulated environment and interact with cross-functional teams and external stakeholders.

Bangalore

Responsible for batch releases by reviewing completed Batch Manufacturing Records (BMR) and associated documentation. Perform final batch release/rejection via SAP. Release batches under quarantine state when necessary. Ensures all GMP’s, work Procedures and SOPs are followed and adheres to internal/external guidelines, specification and regulatory requirements during review and approval of technology transfer documents, BMRs, and dispatch records. Effectively resolve documentation discrepancies and issues with manufacturing operations personnel. Prepare and present Monthly Management Review Meeting slides. One point of contact for client management, including addressing queries, providing updates on the status of batch reviews, and offering support during client audits. Manage and review investigations and change controls related to batch manufacturing, as well as liaise with clients for approvals. Performed gap assessments between procedures to practices followed by revision of SOP with GMP standards. Coordinate periodic surveillance measures and cross-functional team readiness for audits.Overall, I was highly valued for my ability to positively interact with multiple functional areas quickly and effectively resolve batch record documentation related issues, ensuring schedules are maintained.

Chennai Area, India

Managed training initiatives during the transition phase from Hospira to Pfizer, including implementing the LMS success-factor application and role-based curriculum across the site.Played a vital role as LMS Administrator for the site. Developed and implemented job-specific curriculums. Organized and delivered multiple training programs, reaching over 1500 employees, covering topics such as GMP, GDP, Data Integrity awareness, and audit readiness. These sessions were conducted in local languages such as Tamil and Hindi, as well as in English, ensuring accessibility and effectiveness for all participants. Established effective onboarding process. Organized need-based workshops based on audit outcomes.Collaborated with HR to develop and implement tailored training programs focused on employee learning and development, enhancing skill sets and professional growth across the organization.Overall, demonstrated a strong networking skills and expertise in training management.

Chennai Area, India

Training remediation program for both employee and contractor training. Remediate gaps in training compliance.Implements an effective training system to meet the business needs of the organization. Act as SME on the entire site training program and support during regulatory inspections.Organized and delivered multiple training programs such as GMP, GDP, Data Integrity awareness, and audit readiness. These sessions were conducted in local languages such as Tamil and Hindi, as well as in English,emphasizing the significance of the subjects and their alignment with business needs.

Bengaluru Area, India

Responsible for production documentation & control.Issue and review of batch records for upstream and downstream manufacturing.Implemented Electronic Batch Manufacturing Record (BMR) issuance and control, ensuring compliance with GMP requirements. Prepared and reviewed various documentation including BMRs, SOPs, EOPs, SCIs, and SOCs etc. Managed day-to-day manufacturing operations to meet monthly targets.Conducted regular internal GMP rounds and monitored manufacturing facilities. Compiled and maintained batch data for consistency across processes and generated reports. Actively participated in audit preparations and provided support during regulatory, customer, and corporate audit.

Bengaluru Area, India