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Pharmaceutical Quality Assurance Specialist AP12678346

ADPI LLC New Haven, CT

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Pharmaceutical Quality Assurance Specialist AP12678346

12 Month Contract 

Full Remote - must work EST 

 

Summary:

The Senior Specialist for External Quality will be responsible, with management support, for providing oversight of quality activities associated with commercial and clinical API manufacturing processes to contract manufacturing organizations. The Senior Specialist contributes and supports the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Contract Manufacturing oversight and quality systems including Change Control, Deviations and CAPA's. Performs’ all responsibilities in accordance with company policies, procedures, and regulations.

 

Qualifications:

  • Minimum 5 years’ experience of API/Small molecule drug substance/drug product/finished product manufacturing processes in a cGMP environment.
  • Must have knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing.
  • Must have knowledge of small molecule/API manufacturing.
  • Minimum of 5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry
  • Experience working with contract manufacturing organisations
  • Ability to provide project leadership and guide successful completion of Quality projects
  • Excellent written and verbal communication and negotiating skills
  • Risk assessment and risk management
  • Ability to exercise judgment with defined procedures and practices to determine appropriate action
  • Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment
  • Ability to monitor and report on assigned tasks, goals, and objectives.
  • Ability to operate efficiently in a complex matrix organization and international environment
  • Strong mature leadership and interpersonal influencing skills
  • Efficient in Documentation Quality Systems and Trackwise.

 

Education:

Bachelor’s degree required; preference given to candidates with advanced degrees

 

Principal Responsibilities:

  • Serve as Quality Assurance support and SME for API/Small Molecule Drug Substance, Drug Product and Finished Product clinical and commercial manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant. Knowledge and understanding of Small Molecule Drug Substance manufacture and Technical Transfer preferred.
  • Acts as the Quality the leader with the Clinical Supply Quality teams, EM&O teams and other stakeholders to ensure on time delivery to the clinic and market.
  • Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to API Drug Substance, Drug Product and Finished Product.
  • Provides oversight to continuous quality system improvements and supports implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs
  • Works closely to build relationships with internal and external stakeholders.
  • Works closely with internal cross-functional impacted areas, such as EM&O, Regulatory Affairs,Technical Services, Product Development/Clinical Supply to resolve open issues in a timely manner resulting from record reviews and deviation events
  • Responsible for reviewing contractor documents i.e. Batch records, deviations and change controls to ensure that they comply with procedures and meet standards
  • Approve specific standard operating procedures and controlled documents issued by contract manufacturing organisations.
  • Support contract manufacturing organisation audits, including pre-approval inspections.
  • Develop and issue quality metrics pertaining to the process quality activities.
  • Trends and analyses quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses at Quarterly Management Review meetings, proposes and leads team implementation of appropriate CAPA
  • Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending
  • Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
  • Supports Quality Assurance to guide various projects and technical meetings, as needed
  • Responsible for documenting and reporting compliance issues to management
  • Deputize for the Manager, External Quality during holidays and occasion of absence as required.
  • Any other duties as required by management.
Company Description
ADPI, LLC Premier IT Staffing Company dealing with LARGE Direct Clients Only.

ADPI LLC

ADPI, LLC Premier IT Staffing Company dealing with LARGE Direct Clients Only.

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New Haven, CT
06510 USA

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