仕事内容:
医療機器開発環境におけるコンピュータ化システムバリデーション(CSV)是正活動を支援いただきます。
SOP(標準作業手順書)に従って、各種ドキュメントの作成やテストを行い、バリデーション対応を推進します。
※開発作業はありません。ドキュメント作成・レビューが主業務です。
【主な業務内容】
・SOPに基づくCSV関連文書の作成(要件、設計、テスト計画など)
・設計書/技術文書の作成・更新
・テスト仕様書の作成および実施、エビデンス取得
・ドキュメントレビュー、指摘対応
・システムのバリデーション結果のまとめ、是正処理対応
アピールポイント:
・在宅勤務メイン柔軟な働き方が可能です(必要に応じて出社)
・医療業界におけるバリデーションの知識が身につきます
・論理的思考・文書作成力が活かせる専門性の高い業務
・V字モデルや開発工程の理解をお持ちの方を歓迎
求める人材:
【必須スキル】
・V字開発モデルの理解
・システム開発における機能設計およびテスト経験
・設計書や技術文書の作成経験
・ドキュメントレビューの経験
・論理的思考力および文書化能力
【歓迎スキル】
・医療機器開発に関する業務経験
・CSV(Computer System Validation)またはCSA(Computer Software Assurance)の実務経験
勤務時間・曜日:
原則自由
※稼働時間などお気軽にご相談ください。
休暇・休日:
・年間休日125日以上
・完全週休二日制(土日祝)
・夏季休暇・年末年始休暇
・慶弔休暇
・有給休暇
勤務地:
リモートワーク可能(東京23区)
<受動喫煙対策>
就業場所 原則禁煙(分煙)
(変更範囲:当社の定める就業場所)
アクセス:
〒
東京都新宿区新宿 新宿伊藤ビル9F
(各線 新宿三丁目駅 徒歩4分)
給与:
月給・年収はスキルに応じて判断いたします。
雇用形態は相談可
待遇・福利厚生:
・社会保険完備
・リモートワーク制度
・書籍購入制度
・研修・勉強会補助
・各種表彰制度
・フレックスタイム制度
その他:
面接1回
雇用形態: 業務委託
給与・報酬: 600,000円 - 800,000円 月給
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