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Quality Assurance Validation Specialist

2 months ago

Durham, North Carolina, United States MedPharm (formerly Tergus Pharma) Full time

Position Overview: As a Validation Engineer at MedPharm, you will play a crucial role in delivering validation support for pharmaceutical development and manufacturing processes. This position requires meticulous execution of validation tasks and thorough documentation to ensure compliance with industry standards.

Core Responsibilities:

  1. Site Master Validation Program: Contribute to the administration of the site master validation program and assist in maintaining the validation master plan in accordance with established validation policies.
  2. Pharmaceutical Validation: Develop and execute process validation protocols and summary reports; conduct validation testing and analyze results to confirm acceptability, identify discrepancies, and notify relevant parties.

Specific Duties:

Cleaning Validation:

  1. Collaborate with production teams to create and refine cleaning procedures for cGMP equipment used in pharmaceutical manufacturing.
  2. Provide insights and guidance in establishing cleaning processes for new products, working closely with product development engineers.
  3. Partner with the cleaning verification and validation analytical team to draft and develop cleaning validation protocols.
  4. Review protocols, residue limits, and cleaning validation reports to ensure compliance.
  5. Assess the impact of new or updated Master Batch Records on the Cleaning Validation Program.
  6. Offer technical expertise for pre-validation risk assessments using risk management tools for new compounds.
  7. Advise on potential equipment enhancements or replacements.

Equipment and Utilities Qualification:

  1. Draft and review User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
  2. Prepare and evaluate equipment qualification protocols and summary reports.
  3. Assist in executing equipment qualification protocols and ensure proper documentation.
  4. Oversee production activities during validation events.
  5. Ensure that validation documentation is integrated into the site's GMP documentation database.
  6. Foster a culture of open communication and collaboration within Quality Assurance and across the facility.

Key Competencies:

  1. Accountability: Take ownership of work objectives and deliver results while maintaining high performance standards.
  2. Agility: Adapt positively to change and utilize new practices to achieve goals.
  3. Creativity: Seek opportunities to innovate and enhance processes and services.
  4. Empowerment: Identify ways to expand contributions to the organization and support teammates.
  5. Integrity: Uphold the highest standards of integrity and respect for diverse backgrounds and ideas.
  6. Passion: Demonstrate enthusiasm for the organization and its mission to improve health outcomes.
  7. Attention to Detail: Ensure accuracy and completeness of information, following up on commitments.
  8. Interpersonal Skills: Build and maintain effective relationships with colleagues from diverse backgrounds.