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QA and Regulatory Affairs Senior Exe/Assistant HR Manager(ISO9001/13485)

Job Title: QA and Regulatory Affairs Senior Exe/Assistant HR Manager(ISO9001/13485)
Location: Singapore
Reference: DB89B6627F22C5AE
Job Published: October 13, 2018 13:56

Job Description

Job DescriptionA. Areas of Responsibility The incumbent is responsible to co-ordinate the regulatory affairs and compliance activities for all products produced throughout the world when relate to product, process and labelling. Assist and coordinate with the regulatory authorities about acceptable claims, wordings, performance data and other information requisite for marketing the products. Participate and assist to provide material / information required by Regulatory Authority for import, reimbursement and product registration. Participate in company vigilance system including product recall activity, assisting in assessing the recall class of the recall and assuring that regulatory components of the recall are understood and complied. Coordinate with each department and provide required documentation and gain approval for recalls / withdrawals. Assist compliance to Equipment Qualification / Validation Program, Process and Method validation. Assist to finalize and set up the specification for approved starting raw and packaging materials, bulk solutions and finished products that meet the relevant standard and requirements. Participate and assist for establishment, verification and implementation of all company procedures to comply with cGMP and ISO requirement. Exercises responsibility for employee cGMP training such as employee orientation, Quality Awareness, and Job Training. Exercises responsibility for monitoring and control of the manufacturing process, environment and Plant hygiene including clean rooms. Any other tasks or projects that are being assigned by the immediate supervisor, as and when required. Sustain and Active Quality Management System, such as Management Review, Internal Audit, CAPA and training. Apply appropriate auditing methodologies (sampling techniques, following audit trails, investigations, reporting etc.) Post-marketing review activities such as Customer complaints, feedback and survey. Track and analysis of quality data for non-conformance, CAPA and Change Control. Lead teams in conducting investigations related to non-conformance and /or customer complaints. Update the product technical files including risk analysis and product review. Update the relevant standard, regulatory guideline and essential requirement. Ensure documentation system comply with cGMP and ISO requirement. Author, review and/or approve documentation as required Standard Operating Procedures(SOPs), applicable deviation reports for testing, machine equipment and process related deviations etc). Co-ordinate to update Master list for all documentation. Validation plan, Calibration Program and product/ Material code. Make sure only approved supplier and approved material are used in manufacturing process. Monitor and evaluate the performance of suppliers to comply with cGMP and ISO requirement. Make sure product and material storage condition comply with the requirements of cGMP requirement and relevant standard. Make sure production methods comply with the requirements of cGMP requirement, relevant standard and SOP. Reject, rework and dispose of Non-conforming material and product. Co-ordinate design control approvals which associated with R&D activities, new product introductions or significant product changes. Assist on the standard and regulatory correctness of labelling, including promotional material. Make sure that permanent, temporary and emergency changes to production facilities are not compromised to existing product quality and prevent new hazards and risk from being introduced into the process so that the integrity of the quality control system is maintained.B. Challenges of Position The position requires the incumbent to be self-motivated to keep up with the current practices and independent decision-making.C. Communication Network The incumbent must be able to communicate with his/her staffs to ensure understanding and compliance of work tasks.D. Measurement The incumbent will be measured by success in achieving good QA and Regulatory affairs KPIs.E. Requirements (minimum qualification and competencies) Diploma/Degree in Science (Biology, Chemistry, Pharmaceutical). Scientifically, materials, products and process evaluation or validation required by rules and regulations with relevant education and experience. In-depth knowledge of the cGMP, US FDA QSR and 21 CFR, EU MDD, ISO standards such as ISO 9001, ISO 13485. Demonstrated success in preparation of regulatory marketing submission to HSA, EU and other regulatory agencies. Working knowledge of data analysis techniques and product performance testing. Understanding of law, regulation and pending regulation. Understands competitive product features in comparison to products. Provides statistical analysis for evaluation of processes. Knowledge of basic technology employed by the business such as BFS technology, API aseptic manufacturing. Equipment and utility IQ/OQ/PQ/PV. Identifying, writing evaluating and closing OOSs and investigations. Leadership caliber. Gather metric information to use for continuous improvement in areas of responsibility. Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information and communicating priorities clearly and concisely whilst under crisis situations to ensure compliance. Candidate must possess at least a Diploma, Advanced/Higher/Graduate Diploma, Bachelor's Degree, Post Graduate Diploma, Professional Degree, Pharmacy/Pharmacology, BioTechnology, Engineering (Bioengineering/Biomedical) or equivalent.At least 3 year(s) of working experience in the related field is required for this position.Preferably Senior Executives specializing in Quality Control/Assurance, Biotechnology or equivalent.Full-Time position(s) available. Please submit resumes to with the following details in MS Word format: - Position applying for- Current remuneration- Expected remuneration- Notice period John Goh Meng Chye EA License No : 06C4642EA Reg No : R1102621 We regret that only shortlisted candidates will be notified.