Yuvika Rajkumar Email & Phone Number

Sweden

•Preparation of Validation Master Plan (VMP) in line with company’s strategy and regulatory guidelines.•Responsible for process validation, provides guidance to personnel executing validation protocols (Installation Qualification/Operational Qualification/Process Qualification).•Review and assess changes and their impact on validation status following appropriate change control procedures and thereafter action accordingly.•Clean room validations (ISO Class 7 and 8) – acc to, ISO 14644.•Sterilization validation execution and review, on site and external – ISO 11135 (EO) and ISO 11137 (Gamma Irradiation).•Planning, reporting and performing of internal audits and external supplier audits ensuring compliance of management systems with ISO 9001, 13485, 11135, 11137 and regulatory requirements.•Non-conformance reporting which arises from the product, process, quality system, audits and/or customer complaints and follow ups which include RCA and CAPA responses.•Responsible for compiling & the execution of Transport Validation.•Coordinating and managing of project timelines and budgets and initiating CAPEX's accordingly.•Fulfill the role of Laboratory Nominated Representative (NR) and Technical Signatory (TS) towards ISO 17025 – SANAS Accreditation.•Creation and maintenance of the QMS for the Micro lab in line with ISO 17025. This includes all key processes, SOP’s, WI’s, test methods, qualification of lab and lab equipment.•Manages administrative functions to ensure smooth and efficient operations of the Micro Laboratory according to GLP, ISO 17025, ISO 13485, ISO 14001, ISO 11737 and ISO 14644.•Oversees the implementation of human resources policies, procedures and practices including the development of job description for all employees in the Micro Lab.

-Updating and implementing standard procedures, work instructions, technical specifications and Quality Manuals.-Calibration and verification of laboratory equipment with associated IQ, OQ and PQ as required.-Liaising with internal and external stakeholders for conducting and co-ordination of product trials.-Chairing of New Product Development meetings, to review and update the status of various projects and report to management.-Process, equipment and product validations in line with regulatory requirements and thecompilation/maintenance of design history files for specific products.-Coordinating and managing of project timelines and budgets and initiating CAPEX's accordingly.-Sterilization validation and verification of medical devices products.-Clean room validations (ISO Class 7 and 8).-Non conformance reporting and follow ups which include root cause analysis and CAPA responses-Internal auditing and reporting.-Ensure laboratory and department compliance to GLP, GMP, ISO 17025, ISO 13485, ISO 14001, ISO 11737 and ISO 14644.-Laboratory management and inventory keeping.-Bioburden and sterility testing on raw materials, semi and finished medical devices based on ISO 11737 methods.-Development, validation and verification of test methods.-Quality control and assurance of Microbiology laboratory.-Environmental hygiene monitoring of all production areas.-Writing of laboratory and product development reports and test trend monitoring.

Vrede, Free State

EMPLOYMENT DUTIES:• Training workers on GMP/GLP/HACCP in accordance to ISO 22000.• Quality assurance of all outgoing finished feed and incoming raw material results (sieve, durability, urease and NIR tests). Ensuring all finished products are in nutritional, microbiological and sensory specification.• Mycotoxin testing of various feed and raw materials.• In charge of monthly Salmonella and TEC detection dust swabs, dust spatula samples and microbiological water testing samples.• Conducting internal audits and site inspection to ensure safety and smooth operating of the plant. Investigating factory non-conformance’s and liaising with departmental managers to record corrective and preventative actions.• Calibration of laboratory equipment.• Verifying warehouse stock levels at the beginning of each month.• Documentation control and data capturing on the quality database.• Monthly and weekly submission and follow up of wet chem samples.• Uploading of new feed recipes and formulations onto the electronic system.• Weekly and monthly quality reports.• Collaborating with all departments to update and implement SOP’s.• Working together with management and the Quality department to investigate product complaints and returns. Recording of remedial action taken.