仕事概要
職種 | 技術職(販売、設計、開発、生産管理)/開発、研究、実験、プロジェクトマネージャー |
---|---|
業種 | その他/ |
雇用形態 | 未分類 |
ポジションレベル | その他 |
募集人数 | 1名 |
希望入社時期 | - |
必須語学力 |
英語 (ビジネスレベル) |
活かせる語学 | - |
勤務時間 | その他 |
福利厚生・休暇 |
仕事詳細
<Position Objective/Expectation >
- Drive a continuous Quality Assurance and Compliance improvement mindset within the Operations.
- Provide QA strategic leadership and project management of Quality Assurance ensuring compliance
to applicable regulatory requirements and in cooperation with all relevant functions. The responsibility covers QA GMP activities: QA Infrastructure, Sterility Assurance, Quality Systems, and gives a release judgment.
- Lead the quality-related activities at the site to ensure safe, efficacious and quality products can be supplied in accordance with regulatory and business requirements.
<Job Responsibilities>
- Manage and supervise all activities related to product quality in the Company and ensure that these activities comply with WHO GMP and company GMP
- Co-ordinate other managers to resolve problems that concern product quality.
- Support to approve or reject intermediate products, the products are waiting for packaging and finished – product.
- Review batch records, test records, and support to approve for release when ensuring that all product batches are manufactured in compliance with GMP regulations and meet the requirements of registered.
- Final review and approval of SOP for compliance with current GMPs
- Review Validation Master Plan and ensure implementation of validation/calibration, training, and self-inspection program
- Organize or participate in annual GMP, GLP, and GSP self-inspections and prepare a corrective action plan
- Manage Quality Assurance operation to achieve annual departmental target and budget. Prepare suitable objectives for QA staff and carry out annual performance appraisal
- Take part in training GMP
- Take part in assessing the suppliers
- Hold quality meetings frequently
<Necessary Skill / Experience >
- Gender: Any
- Age: 24 - 32
- Qualification:
+ Bachelor's Degree, major in Pharmacy
+ Must have the Pharmacist Practicing Certificate.
- Experience: Have 2 years of working experience as a QA Staff in the Pharmaceutical field
- Language: English - Business Level
面接について
連絡先
QA Supervisor - Pharmaceutical (Bien Hoa)
RGFタレントソリューションズ株式会社
720 〜 880 USD