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新着求人 GMP監査  (FA-34)
募集職種 外資系製薬企業の Senior Auditing Manger
その他のGMP品質保証の求人はこちら
勤務地 東京
会社概要 非公開
求人要件 As assigned, independently conduct, participate and lead audits and assessments of contract manufacturers, select raw material suppliers and service providers, PGS sites that manufacture and distribute finished product and API, as well as ** Country Office locations that have affiliate quality operations responsibility.
Assess adherence to relevant regulatory GMP guidance documents, * Quality Standards, Functional and local SOPs and ** expectations.
•Assess whether employees are being properly trained for their responsibilities
•Assess continued adequacy of the facilities and equipment being used for manufacturing and testing of finished product and APIs
•Assess the concepts of cGMPs and compliance with requirements in the quality agreement and/or with ** expectations / standards.
•Assess and report weaknesses that could lead to non-compliant manufacturing and/or distribution of products.
•Assure that the facility / supplier / contract manufacturer is executing activities (manufacturing, testing, regulatory compliance) per *Quality agreements / expectations.
•Communicate relevant quality, EHS and business information to the facility / supplier / contract manufacturer in an effort to maintain and enhance the relationship between the audited entity and **.
•As assigned, aid the PGS site or applicable contract manufacturer in preparing for upcoming regulatory inspections
•Applies technical knowledge to influence planning/designing cross functional projects
•Interprets regulatory and business challenges and best practices to recommend improvements and/or solutions to cGMP or compliance issues at sites
必要要件 Bachelor’s Degree, preferably in the natural sciences, or equivalent required. Minimum 10 years progressive, challenging experience in pharmaceutical, biotech industry required (experience to include quality control / assurance, manufacturing, GMP auditing and may include product development) including:
•Experienced in operational risk and compliance management, including experience in Quality auditing across a variety of dosage forms (e.g. analytical, API, biologics, aseptic, drug product, medical device) and “audit targets” (suppliers/contractors/facilities).
•Must understand a variety of quality/operational systems that support contractor and supplier audits and quality supply chain management
•Has a good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations and In-depth knowledge of cGMP regulations trends and expectations and familiar with other GXP concepts and global regulations (FDA, EU, TGA, PIC/S, etc.) and must be capable of understanding and reacting to business and regulatory trends
•Understands GMP requirements (PQSs, local regulations, and regulations where the material / product is marketed), practical understanding of the facility operations and is able to communicate effectively in order to influence desired outcomes
•Is qualified in three or more of the technical skill sets, preferably complex ones (analytical, API, biologics, aseptic, drug product, medical device) applicable to the facility audit. (Recognized Auditor certification preferred).
•Critically evaluates information from the facility and the team and makes clear recommendations, and is able to propose potential solutions.
•Must be adept at managing multiple tasks and changing assignment based on changing priorities. Is willing to proactively propose tasks as needed.
•Good organizational skills (audit preparation, audit conduct, audit tracking) and issuance of audit reports aligned with MSQA audit metric targets.
•Has the ability to recognize symptoms of problems or situations that require further evaluation, analyze symptoms to determine potential causes, suggest possible corrective actions. Can independently determine necessary input from subject matter experts in order to support these activities.
•Ability to work independently and work well in a team as a lead auditor or participant, and an effective communicator to peers, Quality leaders and managers (inside and outside the company).
•Actively works to achieve a balanced audit plan, supportive of urgent audit requests and flexible to changes.
•Audit reports are written to reflect the required style and content, with findings levelled appropriately, and applying ‘write right’ and ‘right first time’ principals.
•Ability to conduct ad hoc Quality assessments (e.g. Data Integrity, due diligence) as required to support business needs.
•Ability to lead or participate in significant business related cross functional projects and contribute to innovative outcomes
年収 能力、経験を考慮の上、当社規程により優遇 
募集背景 非公開 
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