P&G is looking for a Data Scientist with experience in cGMP documentation review. Previous experience in a highly regulated business (Drug Product or Dietary Supplement) and Previous experience in a Quality Assurance, Packaging Dev, or MPD role. This is a hybrid role.

Responsibilities:

• Work with initiative teams during development, initiative planning, and launch of OTC Drug and Dietary Supplement products Leveraging P&G SOPs, US FDA Requirements, and cGMPs provide compliance direction to project teams to ensure all phases of product design, documentation, and delivery meet all standards.
• Assist with translation of above requirements into actionable documentation at the manufacturing facility (master batch records, experimental protocols, validation protocols, validation reports, etc)
• Detailed review and approval of R and D and PS GMP batch records and supporting documentation per Healthcare requirements.
• Detailed review and approval of developmental and commercial level material and product specifications in R and D systems and/or PS systems (Enovia) per Health care requirements.
• Data gathering for risk assessments, Authoring Risk Assessment reports, Review of deviations and investigations to ensure compliance with cGMPs, SOPs, and applicable laws, Draft updates to Contract Manufacturing Quality Assurance Technical Agreements.
• Draft and input to standard operating procedures or processes as a part of simplification efforts.
• Identify and communicate gaps in documentation with technical content owners.

Required Skills:

• Work may extend into evenings/weekends in order to meet project timing.
• Must have attention to detail, excellent communication skills, excellent risk-management skills, and be able to multi-task, prioritizing work to meet required timelines

Education:

• Bachelor’s Degree in Physical Science or Engineering highly desired
• Previous experience in Enovia and Veeva systems highly desired

P&G’s freelancer opportunities are for project-based or other short-term engagements that require specialized skills. Successful candidates for freelancer opportunities will not be considered employees of The Procter & Gamble Company or any of its subsidiaries nor will candidates be eligible for employment benefits. Candidates looking for regular full-time employment opportunities should begin their search here: pgcareers.com.