Senior Specialist, QC Instrument Management
Bristol-Myers Squibb
Senior Specialist, QC Instrument Management
Job Description
その業務に従事する場合にカバーする全範囲、責任が及ぶ範囲、成/否時のビジネスインパクト、グローバルチームとの関わり度合い、対応するステークホルダーの種類と範囲、どの程度上位者のサポートを受けないと期待値を満たさないか、チーム/部の構成員に対するパフォーマンスの極大化（評価/育成/モチベーション/職場環境の適正化）を図る場合に必要な要素、レポート関係に無いチームの取りまとめがある場合はその旨記載し必要な要素を含める。 ・SMEとして下記の役割を上位者のアドバイスを得ながらも、自らの判断に基づいて独立して実行できる。 中間製品及び原材料の複雑及び非複雑な方法の試験（ルーチンテスト、環境モニタリング、安定性試験等）を個々の役割に応じて実施する。 試験法、SOP等の技術文書を必要に応じて作成し、レビュー及び改訂を行う。 以下の1～7の業務を行い、試験機器の導入から廃棄までのライフサイクルマネジメントを主導する。 1 試験機器の導入計画を主導し、要求仕様を作成する。 2 試験機器の導入・変更・廃止に伴う変更管理を作成し、プロジェクトを主導する。 3 試験機器導入に関するバリデーション計画書及び報告書の作成及びバリデーションの実施を主導する。 4 試験機器/操作の原理を十分に理解し、機器操作手順書の作成を主導する。 5 試験機器の定期的な校正/保守点検のシステムを確立する。また、定期校正/保守点検のスケジュール管理を行い、点検報告書を作成する。 6 試験機器に関するユーザー管理及びデータ管理を主導する。 7 試験機器の故障時の場合は適切な対応をとる。 外部業者に委託する試験機器の校正/保守点検業務に関して、日本のGMP要求事項及びBMS要求事項に適合させる。 試験機器の校正/保守点検のためのMaximo等のITシステムの活用を主導し、システムデータ等の維持管理を行う。 必要な場合は、BMS他サイトとのコミュニケーションをほぼ独立して行う。 上記以外の割り当てられたタスクを実行する。 その業務に従事する場合に必要な知識、スキル、経験、コミュニケーション（言語力含む）/協力のレベル、深さ、範囲と言った要素を含む。 (Range of knowledge/skills/experience required and degree/depth/scope of communication (Inc. language skill)/corroboration.) 国内外のGMP要求事項及びBMS社内GMP要求事項を理解し、適用できるスキル 日本薬局方を理解し、適用できるスキル 業界のベストプラクティスを情報収集し、適用できるスキル 技術文書（バリデーション文書、操作手順書等）を作成できるスキル 問題解決能力・メンタリティを持ち、技術的に精通し、論理的思考を持つ タスクの完了、ニーズに関して、同僚またはステークホルダーと効果的にコミュニケーションをとるスキル ペースの速いチーム環境で業務を遂行し、複数のタスクの期限を管理し、優先順位を付けできるスキル 英語で読み書き、会話ができるスキル 関連分野で5年以上の経験を持つ学士号、または3年以上の経験を持つ修士号、または1年以上の経験を持つ博士号、または 非関連分野で9年以上の経験を持つ学士号、または同等の教育と経験の組み合わせの知識
Key Responsibilities
- Conduct testing of intermediate products and raw materials using both complex and non-complex methods (routine tests, environmental monitoring, stability tests, etc.)
- Create, review, and revise technical documents such as test methods and SOPs as needed
- Lead the lifecycle management of test equipment from introduction to disposal, including:
- . Leading the development of test equipment introduction plans and creating requirement specifications
- . Creating change management for test equipment introduction, changes, and decommissioning, and leading the project
- . Leading the creation and execution of validation plans and reports for test equipment introduction
- . Leading the creation of equipment operation manuals with a thorough understanding of equipment and operation principles
- . Establishing a system for periodic calibration and maintenance inspections of test equipment, managing schedules, and creating inspection reports
- . Leading user and data management related to test equipment
- . Taking appropriate action in case of test equipment failure
- Ensure calibration and maintenance inspections of test equipment outsourced to external vendors comply with Japanese GMP and BMS requirements
- Lead the use of IT systems like Maximo for test equipment calibration and maintenance, and maintain system data
- Communicate almost independently with other BMS sites as needed
- Execute other assigned tasks
Required Qualifications
- Bachelor's degree with at least 5 years of experience in a related field
- Master's degree with at least 3 years of experience in a related field
- Doctoral degree with at least 1 year of experience in a related field
- Bachelor's degree with at least 9 years of experience in an unrelated field, or equivalent combination of education and experience
- Understanding and application of domestic and international GMP requirements and BMS internal GMP requirements
- Understanding and application of the Japanese Pharmacopoeia
- Ability to gather and apply industry best practices
- Skill in creating technical documents such as validation documents and operation manuals
- Problem-solving skills and technical proficiency with logical thinking
- Effective communication skills with colleagues or stakeholders regarding task completion and needs
- Ability to work in a fast-paced team environment, manage multiple task deadlines, and prioritize
- Ability to read, write, and converse in English
Skills Required
- Understanding and application of domestic and international GMP requirements and BMS internal GMP requirements
- Understanding and application of the Japanese Pharmacopoeia
- Ability to gather and apply industry best practices
- Skill in creating technical documents such as validation documents and operation manuals
- Problem-solving skills and technical proficiency with logical thinking
- Effective communication skills with colleagues or stakeholders regarding task completion and needs
- Ability to work in a fast-paced team environment, manage multiple task deadlines, and prioritize
- Ability to read, write, and converse in English
Locations
- Aichi, Japan
Salary
Estimated Salary Rangemedium confidence
6,000,000 - 9,000,000 JPY / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Understanding and application of domestic and international GMP requirements and BMS internal GMP requirementsintermediate
- Understanding and application of the Japanese Pharmacopoeiaintermediate
- Ability to gather and apply industry best practicesintermediate
- Skill in creating technical documents such as validation documents and operation manualsintermediate
- Problem-solving skills and technical proficiency with logical thinkingintermediate
- Effective communication skills with colleagues or stakeholders regarding task completion and needsintermediate
- Ability to work in a fast-paced team environment, manage multiple task deadlines, and prioritizeintermediate
- Ability to read, write, and converse in Englishintermediate
Required Qualifications
- Bachelor's degree with at least 5 years of experience in a related field (experience)
- Master's degree with at least 3 years of experience in a related field (experience)
- Doctoral degree with at least 1 year of experience in a related field (experience)
- Bachelor's degree with at least 9 years of experience in an unrelated field, or equivalent combination of education and experience (experience)
- Understanding and application of domestic and international GMP requirements and BMS internal GMP requirements (experience)
- Understanding and application of the Japanese Pharmacopoeia (experience)
- Ability to gather and apply industry best practices (experience)
- Skill in creating technical documents such as validation documents and operation manuals (experience)
- Problem-solving skills and technical proficiency with logical thinking (experience)
- Effective communication skills with colleagues or stakeholders regarding task completion and needs (experience)
- Ability to work in a fast-paced team environment, manage multiple task deadlines, and prioritize (experience)
- Ability to read, write, and converse in English (experience)
Responsibilities
- Conduct testing of intermediate products and raw materials using both complex and non-complex methods (routine tests, environmental monitoring, stability tests, etc.)
- Create, review, and revise technical documents such as test methods and SOPs as needed
- Lead the lifecycle management of test equipment from introduction to disposal, including:
- . Leading the development of test equipment introduction plans and creating requirement specifications
- . Creating change management for test equipment introduction, changes, and decommissioning, and leading the project
- . Leading the creation and execution of validation plans and reports for test equipment introduction
- . Leading the creation of equipment operation manuals with a thorough understanding of equipment and operation principles
- . Establishing a system for periodic calibration and maintenance inspections of test equipment, managing schedules, and creating inspection reports
- . Leading user and data management related to test equipment
- . Taking appropriate action in case of test equipment failure
- Ensure calibration and maintenance inspections of test equipment outsourced to external vendors comply with Japanese GMP and BMS requirements
- Lead the use of IT systems like Maximo for test equipment calibration and maintenance, and maintain system data
- Communicate almost independently with other BMS sites as needed
- Execute other assigned tasks
Tags & Categories
Senior Specialist, QC Instrument Management
Bristol-Myers Squibb
Senior Specialist, QC Instrument Management
Job Description
その業務に従事する場合にカバーする全範囲、責任が及ぶ範囲、成/否時のビジネスインパクト、グローバルチームとの関わり度合い、対応するステークホルダーの種類と範囲、どの程度上位者のサポートを受けないと期待値を満たさないか、チーム/部の構成員に対するパフォーマンスの極大化（評価/育成/モチベーション/職場環境の適正化）を図る場合に必要な要素、レポート関係に無いチームの取りまとめがある場合はその旨記載し必要な要素を含める。 ・SMEとして下記の役割を上位者のアドバイスを得ながらも、自らの判断に基づいて独立して実行できる。 中間製品及び原材料の複雑及び非複雑な方法の試験（ルーチンテスト、環境モニタリング、安定性試験等）を個々の役割に応じて実施する。 試験法、SOP等の技術文書を必要に応じて作成し、レビュー及び改訂を行う。 以下の1～7の業務を行い、試験機器の導入から廃棄までのライフサイクルマネジメントを主導する。 1 試験機器の導入計画を主導し、要求仕様を作成する。 2 試験機器の導入・変更・廃止に伴う変更管理を作成し、プロジェクトを主導する。 3 試験機器導入に関するバリデーション計画書及び報告書の作成及びバリデーションの実施を主導する。 4 試験機器/操作の原理を十分に理解し、機器操作手順書の作成を主導する。 5 試験機器の定期的な校正/保守点検のシステムを確立する。また、定期校正/保守点検のスケジュール管理を行い、点検報告書を作成する。 6 試験機器に関するユーザー管理及びデータ管理を主導する。 7 試験機器の故障時の場合は適切な対応をとる。 外部業者に委託する試験機器の校正/保守点検業務に関して、日本のGMP要求事項及びBMS要求事項に適合させる。 試験機器の校正/保守点検のためのMaximo等のITシステムの活用を主導し、システムデータ等の維持管理を行う。 必要な場合は、BMS他サイトとのコミュニケーションをほぼ独立して行う。 上記以外の割り当てられたタスクを実行する。 その業務に従事する場合に必要な知識、スキル、経験、コミュニケーション（言語力含む）/協力のレベル、深さ、範囲と言った要素を含む。 (Range of knowledge/skills/experience required and degree/depth/scope of communication (Inc. language skill)/corroboration.) 国内外のGMP要求事項及びBMS社内GMP要求事項を理解し、適用できるスキル 日本薬局方を理解し、適用できるスキル 業界のベストプラクティスを情報収集し、適用できるスキル 技術文書（バリデーション文書、操作手順書等）を作成できるスキル 問題解決能力・メンタリティを持ち、技術的に精通し、論理的思考を持つ タスクの完了、ニーズに関して、同僚またはステークホルダーと効果的にコミュニケーションをとるスキル ペースの速いチーム環境で業務を遂行し、複数のタスクの期限を管理し、優先順位を付けできるスキル 英語で読み書き、会話ができるスキル 関連分野で5年以上の経験を持つ学士号、または3年以上の経験を持つ修士号、または1年以上の経験を持つ博士号、または 非関連分野で9年以上の経験を持つ学士号、または同等の教育と経験の組み合わせの知識
Key Responsibilities
- Conduct testing of intermediate products and raw materials using both complex and non-complex methods (routine tests, environmental monitoring, stability tests, etc.)
- Create, review, and revise technical documents such as test methods and SOPs as needed
- Lead the lifecycle management of test equipment from introduction to disposal, including:
- . Leading the development of test equipment introduction plans and creating requirement specifications
- . Creating change management for test equipment introduction, changes, and decommissioning, and leading the project
- . Leading the creation and execution of validation plans and reports for test equipment introduction
- . Leading the creation of equipment operation manuals with a thorough understanding of equipment and operation principles
- . Establishing a system for periodic calibration and maintenance inspections of test equipment, managing schedules, and creating inspection reports
- . Leading user and data management related to test equipment
- . Taking appropriate action in case of test equipment failure
- Ensure calibration and maintenance inspections of test equipment outsourced to external vendors comply with Japanese GMP and BMS requirements
- Lead the use of IT systems like Maximo for test equipment calibration and maintenance, and maintain system data
- Communicate almost independently with other BMS sites as needed
- Execute other assigned tasks
Required Qualifications
- Bachelor's degree with at least 5 years of experience in a related field
- Master's degree with at least 3 years of experience in a related field
- Doctoral degree with at least 1 year of experience in a related field
- Bachelor's degree with at least 9 years of experience in an unrelated field, or equivalent combination of education and experience
- Understanding and application of domestic and international GMP requirements and BMS internal GMP requirements
- Understanding and application of the Japanese Pharmacopoeia
- Ability to gather and apply industry best practices
- Skill in creating technical documents such as validation documents and operation manuals
- Problem-solving skills and technical proficiency with logical thinking
- Effective communication skills with colleagues or stakeholders regarding task completion and needs
- Ability to work in a fast-paced team environment, manage multiple task deadlines, and prioritize
- Ability to read, write, and converse in English
Skills Required
- Understanding and application of domestic and international GMP requirements and BMS internal GMP requirements
- Understanding and application of the Japanese Pharmacopoeia
- Ability to gather and apply industry best practices
- Skill in creating technical documents such as validation documents and operation manuals
- Problem-solving skills and technical proficiency with logical thinking
- Effective communication skills with colleagues or stakeholders regarding task completion and needs
- Ability to work in a fast-paced team environment, manage multiple task deadlines, and prioritize
- Ability to read, write, and converse in English
Locations
- Aichi, Japan
Salary
Estimated Salary Rangemedium confidence
6,000,000 - 9,000,000 JPY / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Understanding and application of domestic and international GMP requirements and BMS internal GMP requirementsintermediate
- Understanding and application of the Japanese Pharmacopoeiaintermediate
- Ability to gather and apply industry best practicesintermediate
- Skill in creating technical documents such as validation documents and operation manualsintermediate
- Problem-solving skills and technical proficiency with logical thinkingintermediate
- Effective communication skills with colleagues or stakeholders regarding task completion and needsintermediate
- Ability to work in a fast-paced team environment, manage multiple task deadlines, and prioritizeintermediate
- Ability to read, write, and converse in Englishintermediate
Required Qualifications
- Bachelor's degree with at least 5 years of experience in a related field (experience)
- Master's degree with at least 3 years of experience in a related field (experience)
- Doctoral degree with at least 1 year of experience in a related field (experience)
- Bachelor's degree with at least 9 years of experience in an unrelated field, or equivalent combination of education and experience (experience)
- Understanding and application of domestic and international GMP requirements and BMS internal GMP requirements (experience)
- Understanding and application of the Japanese Pharmacopoeia (experience)
- Ability to gather and apply industry best practices (experience)
- Skill in creating technical documents such as validation documents and operation manuals (experience)
- Problem-solving skills and technical proficiency with logical thinking (experience)
- Effective communication skills with colleagues or stakeholders regarding task completion and needs (experience)
- Ability to work in a fast-paced team environment, manage multiple task deadlines, and prioritize (experience)
- Ability to read, write, and converse in English (experience)
Responsibilities
- Conduct testing of intermediate products and raw materials using both complex and non-complex methods (routine tests, environmental monitoring, stability tests, etc.)
- Create, review, and revise technical documents such as test methods and SOPs as needed
- Lead the lifecycle management of test equipment from introduction to disposal, including:
- . Leading the development of test equipment introduction plans and creating requirement specifications
- . Creating change management for test equipment introduction, changes, and decommissioning, and leading the project
- . Leading the creation and execution of validation plans and reports for test equipment introduction
- . Leading the creation of equipment operation manuals with a thorough understanding of equipment and operation principles
- . Establishing a system for periodic calibration and maintenance inspections of test equipment, managing schedules, and creating inspection reports
- . Leading user and data management related to test equipment
- . Taking appropriate action in case of test equipment failure
- Ensure calibration and maintenance inspections of test equipment outsourced to external vendors comply with Japanese GMP and BMS requirements
- Lead the use of IT systems like Maximo for test equipment calibration and maintenance, and maintain system data
- Communicate almost independently with other BMS sites as needed
- Execute other assigned tasks
Tags & Categories