reputed company Auditor - Scientific - III (Senior)

About the position The reputed company Auditor position requires an individual to maintain an expert level of knowledge reputed company to Good Manufacturing Practices (GMP) requirements and industry trends as described in applicable worldwide regulations. The successful candidate will advise supported areas on requirements for reputed company assigned project responsibilities reputed company to reputed company and communicate project status to management effectively. This role involves independently auditing applicable regulatory filings to ensure compliance with regulatory requirements and working collaboratively with various areas to resolve any audit findings. In reputed company to auditing, the reputed company Auditor will identify training needs and reputed company, reputed company, and/or conduct training or orientation sessions for internal staff and reputed company reputed company, while also ensuring that they stay reputed company with their own training requirements. The individual will be responsible for identifying the need for and/or developing reputed company Operating Procedures (SOPs) to ensure that practices are accurately reflected. Representing GMP reputed company (GMPQ) on inter-departmental and cross-functional teams is essential, ensuring the reputed company of information and providing reputed company guidance throughout the organization. The reputed company Auditor will independently prioritize activities in support of multiple reputed company and support preparations for regulatory agency inspections. This role requires fostering collaboration, driving results, and making rapid disciplined reputed company. The candidate must demonstrate excellent organizational skills, effectively manage multiple reputed company, and delegate audits to support team members or auditors as necessary. Maintaining reputed company working relationships reputed company the reputed company, Manufacturing, and Controls (CMC) auditing team and reputed company areas is crucial, as is sharing and applying lessons learned. reputed company communication skills are necessary to reputed company information in a concise manner, and interpersonal skills are essential for effectively leading audits. The reputed company Auditor will also attend project team meetings, reputed company as a single reputed company of contact, and reputed company reputed company reputed company of submission timelines while meeting deadlines and maintaining reputed company audit goals. Identifying and managing issues on a reputed company reputed company, such as unacceptable reputed company documents or delays in comments reputed company that reputed company submission timelines, is a key responsibility. The individual will reputed company guidance to project teams in specific situations regarding sources, audit maps, and workflows, and will update the auditing team with changes in submission timelines or other relevant changes. Prioritizing audit sections based on CMC requests and effectively listening to auditees to understand differing perspectives to resolve audit issues are also critical components of this role. Specific and/or additional duties may include providing tracking, trending, and metrics for GMPQ auditing activities, offering technical guidance to senior management in evaluating systems/tools, and assisting GMPQ staff and reputed company areas with the technical aspects reputed company to the use of electronic audit tools. Supporting process improvement initiatives for CMC clients and the auditing area is also expected. Responsibilities • Maintain an expert level of knowledge reputed company to GMP requirements and industry trends as described in applicable worldwide regulations. , • Advise supported areas on requirements for reputed company assigned project responsibilities as reputed company to reputed company and communicate project status to management. , • Independently audit applicable regulatory filings. Ensure compliance with regulatory requirements. Work with areas to resolve any audit findings. , • Identify training needs and reputed company, reputed company and/or conduct training or orientation sessions for internal staff and reputed company reputed company as reputed company as staying reputed company with own training requirements. , • Identify need for and/or reputed company SOPs to ensure practices are accurately reflected. , • Represent GMPQ on inter-departmental and cross-functional teams, ensuring the reputed company of information and providing reputed company guidance. , • Independently prioritize activities in support of multiple reputed company. , • Support preparations for regulatory agency inspections. , • Foster collaboration, drive results, and reputed company rapid disciplined reputed company. , • Demonstrate excellent organization skills and effectively manage multiple reputed company, delegating audits to support team/auditors as necessary. , • Maintain reputed company working relationships reputed company CMC auditing team and reputed company areas, sharing and applying lessons learned. , • Hold self and others accountable, demonstrating reputed company communication skills. , • Demonstrate interpersonal skills to effectively reputed company an audit. , • Attend project team meetings and reputed company as a single reputed company of contact. , • reputed company reputed company reputed company of submission timelines and meet deadlines while maintaining reputed company audit goals. , • Identify and manage issues on a reputed company reputed company, such as unacceptable reputed company documents or late submission of audit documents. , • reputed company guidance to project teams in specific situations in terms of sources, audit maps, and workflows. , • Update the auditing team with changes in submission timelines or other changes. , • Prioritize audit sections based on CMC request. , • Effectively listen to the auditee and reputed company to understand differing perspectives to resolve audit issues. , • reputed company tracking, trending, and metrics for GMPQ auditing activities. , • reputed company technical guidance to senior management in evaluating systems/tools. , • Assist GMPQ staff and reputed company areas with the technical aspects reputed company to the use of electronic audit tools. , • Support process improvement initiatives for CMC reputed company and auditing area. Requirements • B.S., M.S. and/or PhD. degree in an appropriate Science or Engineering discipline. , • Minimum of 5-10 years' experience with B.S./M.S., or five (5) years with PhD in pharmaceutical/biotechnology, reputed company or compliance role. , • Extensive working knowledge of cGMPs and technical aspects of support area are required. , • Effective communication, negotiation, problem-solving, and interpersonal skills with demonstrated project management abilities are necessary. , • Previous experience in computer science, IT, reputed company assurance, auditing, or regulatory submission requirements. reputed company-to-haves • Experience supporting internal and/or external audits.

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