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Experience in APIs (General, Sterile & non-sterile Oncology, Hormones, Steriods, Narcotics), Formulation (OSD), Supplier qualification & quality audits. A subject matter expert with over 18+ years of experience in Quality Management & Control ranging from Quality Assurance, Audit & Compliance, Quality & Microbiology lab Control, managing contract manufacturing sites including technology transfer, analytical method transfer, planning & execution of validation & commercial batches, dispatch activities from CMO sites, monitoring & approval of QC related activities like analytical method validation, cleaning method validation, instrument calibrations, review of audit trail & approval of analytical data for routine testing, audit of external testing laboratories. Handled CRO related activities i.e. auditing of CRO facility as a part of qualification, monitoring BE studies to meet scheduled timeline, auditing the patient related data etc. 4 years of work experience in Environment management i.e. turnkey design of Effluent Treatment Plant & Incineration system, conducting Environmental Audits & preparing the Environment Audit reports, making application for Environment licenses like CCA, NOC. Executed the project of Cleaner Production lead by GIDC Chairman & MD (IAS Officers) for the optimization of manufacturing processes for zero discharge / effluent reduction & for the conservation of energy & raw materials in ten of the industries of Ankleshwar & was nominated for the Young Best Chemical Engineer Award for the successful completion of Cleaner Production project. 1 year of work experience as Production Head. Leading manufacturing activities of 10 manufacturing blocks which are engaged in the manufacturing of general category APIs, Steriods, Hormones & Narcotics.

Results-driven Quality Control Manager with a Doctorate in Chemistry and over 19 years of experience in the pharmaceutical industry, specializing in Quality Control, Analytical R&D, and Quality Assurance Compliance. Proven expertise in managing and leading teams to meet project timelines while ensuring adherence to regulatory standards such as ISO 9001:2015 and 21 CFR. Demonstrated success in implementing LEAN lab management processes, conducting method transfers and validations, and managing CAPA and Change Control initiatives. Adept at enhancing productivity through strategic planning and execution within biopharmaceuticals, aseptic manufacturing, and controlled substance environments.

A highly efficient, hardworking Personal who has considerable experience of developing and implementing effective quality procedures in a manufacturing and corporate environment is looking for a challenging and rewarding position that leverages my education, experience and technical skills in ways . Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success. Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.

Manohara Repalle

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Analytical Quality Assurance

Executive at Quality Control Lab

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Analyst

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Master of Pharmacy - Quality Control And Quality Assurance

Bachelor of Pharnacy - B.pharmacy

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SSC -

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Analytical Quality Assurance

Executive at Quality Control Lab

Analyst

Analyst

Master of Pharmacy - Quality Control And Quality Assurance

Bachelor of Pharnacy - B.pharmacy

High School Diploma -

SSC -

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