東京都 区, 株式会社Caluck Remote job

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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