Senior Auditor R&D Quality Assurance

Quality Carmel, New York


Description

This position is responsible for supporting the quality and compliance of documentation generated by and activities of Research and Development (R&D), which includes Product Development (PD) and Analytical R&D (AR&D).

Responsibilities include but are not limited to:

  • Assist in the development of appropriate policies and procedures in R & D to ensure compliance cGMP and ICH requirements (to include ICH Q8, Quality by Design).
  • Leverage design control and risk management knowledge and experience to ensure product development documents are in compliance with Food and Drug Administration (FDA)regulations and guidance, local, and corporate requirements and best practices. These include and are not limited to:
    1. Method Validation Reports/Method Change Control
    2. Laboratory investigations
    3. Protocols/Reports
    4. Product Development Reports
    5. Quality Overall Summaries
    6. ANDA sections, as applicable, and in alignment with RA
  • Support R&D during corporate and third party audits and FDA inspections, as applicable, through preparation and logistical and tactical activity.
  • Support internal audits, as applicable, to ensure regulatory requirements (FDA), standards, and internal procedures are being met.
  • In alignment with site Quality Assurance, review and/or approve Good Manufacturing Practice (cGMP) documentation such as Standard Operating Procedures (SOPs), corporate policies, qualification / validation plans, user requirements specifications (URS), functional and design specifications (FS and DS), testing protocols (IQ/OQ/PQ), user acceptance testing, traceability matrices, validation reports, and change control documentation to support all AR&D laboratory instrument and development pilot plant qualification and associated computer system validation.
  • As a continuous improvement effort, work with R&D and RA to ensure the quality of R&D generated documentation to ensure submission-readiness and right-the-first-time (RTFT).
  • In Alignment with Supplier Quality Management, as required:
    1. Review and approve third parties’ investigations
    2. Review and/or approve cGMP documentation (e.g., validation protocols and reports) from contract developers, manufacturers and testers.
    3.  Support external audits, including FDA inspections.

 

  • Stay up-to-date with industry best practices, industry benchmarks and FDA’s views or current thinking (guidance documents, presentations, etc.).
  • Other duties as required.

Education:

  • Bachelor’s degree or equivalent experience required

Experience:

  • A minimum of 5-10 years of experience in either an R&D role or Quality role
  • Pharmaceutical industry background required

Accountabilities:

This position is accountable for:

  • Complying with established company policies and procedures
  • Functioning in a professional manner and maintaining a high level of business and professional ethics
  • Developing and maintaining mutual support and cooperation between departments and sites

Key Relationships

Internal

The position is designed to support cGMP and regulatory requirements for R&D documentation.  This person will review and approve cGMP protocols, reports, procedures and policies. This position will work in conjunction with Product Development, Analytical R&D, Regulatory Affairs, and Supplier Quality Management, other departments as required.

External

The position will interact with all Lannett sites, and work in conjunction with each site’s R&D and contract developers and manufacturers as required.

Skills and Experience:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  This individual must have extensive knowledge (subject matter expertise) on R&D best practices.  A minimum of 5-10 years of experience in either an R&D role or Quality role performing and developing processes and procedures is required.  A background in the pharmaceutical industry is required.  This individual must possess strong interpersonal communication skills, strong documentation development background and technical writing skills, and the ability to adapt to a rapidly changing environment.

Supervisory Responsibilities:

None

PHYSICAL DEMANDS

None