Process Lead QA-r&d Oversight

4 weeks ago

Ras alKhaimah, United Arab Emirates Julphar Full time

Job Title: Process Lead QA-R&D Oversight Division: QUALITY ASSURANCE Country: UNITED ARAB EMIRATES Work Location: UAE (RAK head office) Job Type: QA - Process Lead - Engineering Oversight Employment Type: Full Time Employment (Limited Contract) Purpose: Receiving & Tracking of R&D deviations and OOS related to Non-sterile, sterile and Biotech. Coordination with R&D for the investigation’s completion and CAPA related to Sterile product, Biotech and Microbiology. Review of all technical documents related to sterile product, Biotech and Microbiology for products, process, Systems for its completeness and adequacy prior to approval from QA Operations Manager. R&D walkthrough to ensure R&D activities complying cGMP requirements. Key responsibilities & Accountability: To assist QA-Operations Manager for ensuring cGMP compliance in R&D. R&D walkthrough to ensure Quality Control activities are complying cGMP requirements. Timely review of R&D related technical documents (SOPs, Specifications, Method Validations, Standard test methods, stability protocols, stability reports, R&D trends etc.) for adequacy of procedure contents. Timely tracking of all deviations and OOS related to R&D. Reviewing and file compilation with all supporting attachments before to final approval Deviation file. Co-ordinate with the related R&D personnel for the investigations completion of deviations and OOS. To coordinate with R&D personnel during reviewing of technical documents (Deviations, OOS and CAPA etc.) in timely closure of the documents. To manage all change controls related to R&D. Actively participate in tackling problems and support other departments, stability OOS investigations. Active participation in External audits. Support in Validation activities as needed. Any other responsibility assigned by QA - Operations Manager. Qualifications: - Education Bachelor/Master degree pharmacy - Experience: Minimum 8-10 years of experience in R&D and QA leadership position Good Computer knowledge and knowledge of QMS system “Agile, Trackwise, Ampelogic” Proficient in English. Quality and Business decisions taker Good Knowledge and command on cGMP Risk Assessment knowledge - Training: Key Competencies: In terms of competency, you are highly result oriented with strong sense of accountability & ownership. High on compliance adherence, having strong attention to detail, proactive and flexible Good communication, interpersonal, and collaboration skills. Having a demonstrated skill in leadership and people management Motivated, organized, focused & overall compliance. Must be able to manage tasks, plan workload effectively, priorities and easily adapt to changing situations. Ability to understand new learnings and implant in workplace. Demonstrate a good capability in People management and conflict resolving Technical Competencies:

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