Job Description

Company Name: Johnson & Johnson Position : Q&C Specialist Working Days/ Hours: Monday - Friday, 0845 to 1745 (time is flexible) Contract Duration: 12 months contract with PERSOLKELLY Salary Range: Basic up to RM2200 - 2800 with statutory contribution Training : On the job training Requirements : A minimum of 1-2 years of QA / QC experience (with hands on testing), in either Pharmaceutical, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production. Fresh graduates are also encouraged to apply. Preferred: Experienced in Good Manufacturing Practices and Quality Management System covering product inspections and releases, process controls, handling of complaints and investigations, knowledge and application of Good Documentation and Data Integrity Practices, Good Laboratory Practices. Good proficiency in English and Malay in terms of communication and writing. Good in analytics and technical writing skills and root cause problem solving. Working Experience (Years):1-2 Qualifications: Diploma or Degree Holder in Science field Responsibilities : To provide support in Quality Assurance / Plant Quality & Compliance for J&J Malaysia manufacturing plant. Ensured all activities and projects executed are well documented and ensure execution in the manner meeting cGMP, Health, Safety and Environmental, regulatory and corporate quality standards and J&J policies. 1. Practice Global Leadership Profile . Strategic Thinking . Intellectual Curiosity . Sense of Urgency . Prudent Risk Taking . Self-Awareness and Adaptability . Result and Performance Driven . Big Picture Orientation with Attention to Detail . Collaboration and Teaming 2. Quality & Compliance Responsibilities . To provide oversight in ensuring site activities, projects, program and initiatives are executed and conforming to established specifications, procedures and in compliance of cGMP and company requirements. . Responsible for all aspects of quality assurance activities of in process and finished products. . Responsible for completeness of documentation prior to release of FG under New Product Development (NPD), cost / quality compliance project with complete Authorization for Product Release (APR) / Global Change Control (GCC) and meeting quality requirement. . To support in NPD/NPI processes to ensure consistency of execution and in compliance of GMP requirements and deliver Q&C deliverables as per requirement. . To support in all quality activities in shopfloor including in process inspection and initiatives to drive compliance and process improvement and robustness which includes global and regional strategic initiatives. . To support end-to-end batch record management (including reconciliation, review, retrieval, retention, arrangement for scanning) as per requirements and support in timely FG release including CoA request for market affiliates). . Responsible for overall standard reference management for FG and ensure accurate and timely phase in of new standard reference. 3. Documentation Control Responsibilities . Ensure batch records management and control (which includes reconciliation, storage, protection, retrieval, retention and disposition of records) are in place to provide evidence of conformity to requirement . To ensure that procedures, work instructions, specifications, COA and relevant records are available, maintained and current. 4. Self-Development . To keep abreast of new technology, among other means, is by direct communication with other company Affiliates and Originating Company, have indepth knowledge of products/raw material in order to provide technical support for new product introduction or profit improvement projects. . Proactively pursue self-learning to complete the competency requirement as per Competency model. . Be a team member . To ensure PDP cycle is observed for performance evaluation, training needs identification and analysis and training plan implementation. 5. GMP and SHE (Safety Health and Environmental) compliance. . Ensure team/division compliance to SH&E and GMP . Adhere to cGMP and cGLP at all times. . To ensure workstation are clean and orderly Send your updated resume to [HIDDEN TEXT]

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