HireDiversity

Fort Washington, PA, US

QA SAP VALIDATION LEAD, CD (1 of 4)-8783120824

Description

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a QA Validation Lead, SAP located in Fort Washington, PA or Skillman, NJ

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB, Mylanta and ROLAIDS® antacid products, and SUDAFED® nasal decongestants.

McNeil-PPC, Inc. entered into a consent decree, or agreement, with the agency that governs certain manufacturing operations to help ensure quality and compliance. Now is an exciting time to join our business, as we focus on reaffirming the integrity of our iconic brands that are staples of households worldwide. Whether you view this opportunity as a potential career accelerator here, within the J&J family of companies or beyond, or whether this is your entry to the J&J family of companies, we invite you to join us….

Creating the future of McNeil

The CSV QA Validation Lead, is responsible for ensuring that GxP regulated computerized are in full compliance with regulatory requirements, company policies and procedures. Provide compliance leadership, direction and oversight to project teams in Computer System Validation. This individual is responsible for the quality oversight of GxP regulated computerized (e.g. manufacturing plant systems, laboratory systems and enterprise applications). This individual will support leadership and compliance support activities include, but are not limited to SOP revisions, validation documentation review and approval (including but not limited to change controls, risk assessments, compliance plans, user requirements, system and user acceptance testing protocols, test scripts, traceability matrix, error reports/defect report forms, and summary reports). The incumbent will be responsible for the QA release of regulated systems for GxP production use. This individual will support the 24/7 operations of the manufacturing plant, resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 820, 11 and Annex 11). In addition, this individual will lead and participate in project teams and may participate in regulatory inspections (e.g. FDA).

Qualifications


This position requires a minimum of a Bachelor's Degree. An Advanced Degree is preferred. A degree in a technical, scientific or related field is preferred. A minimum of 6 years of industry experience is required with at least 3 years of CSV SDLC, Validation or QA experience. Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11 and Part 820 is required. Experience with Health Authority Inspections is preferred. Strong knowledge of SAP and HPQC is preferred. This position will be located in Fort Washington, PA or Skillman, NJ and may require up to 10% travel.

The QA SAP Validation Lead will be focused on Consent Decree work through December 2014. Post Consent Decree work will support the Consumer Business.

Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)