Job Id: LS1326151MR_1677615837 Apply Now

ROLE SUMMARY

The Lead Investigator P&I will provide guidance, coaching and coordination for all aspects related to the initiation, tracking, trending and management of all manufacturing investigations, corrective and preventive actions (CAPA), evaluation of CAPA effectiveness and Operational Excellence projects within Operations (Manufacturing, Inspection and Packaging).

The incumbent will work with the Operations leadership team and Quality Assurance to facilitate the consistent, disciplined execution of the ER/QAR quality system ensuring the completeness and comprehension of the investigations and determination of most probable root cause. This position will review and analyze corrective and preventive actions effectiveness through appropriate tracking and trending methods in order to prevent reoccurrence. The incumbent is also in charge of developing and issuing weekly and monthly reports that assess organizational, process and product performance.

ROLE RESPONSIBILITIES

Manufacturing Investigations:

• Facilitates adequate completion of manufacturing investigation efforts at the operations to ensure compliance with quality and cycle time standards. Works closely, provides guidance, coaching and feedback to all groups who are involved in initiating, completing and conducting manufacturing investigations and CAPA analysis.

CAPA Analysis:

• Gathers and analyzes historical data to identify trends and root-cause of manufacturing deviations. Recommends corrective and preventive actions to prevent/ eliminate recurrent discrepancies and leads its implementation in Operations. Measures CAPA effectiveness.

QAR Quality System:

• Ensures that QAR System requirements are being executed as established in the site's SOP and corporate guidelines. Provides the necessary coaching and guidance to ensure practices are in compliance with guidelines. Is the primary contact in the resolution of conflicts and differences resulting from the resolution of MIRs.

Training and Education:

• Collaborates in the design and deployment of trainings to educate employees on how to report, initiate, conduct and close an investigation. Manages the QAR Certification Program and ensures its adequate implementation in Operations. Leads efforts to educate leaders and employees on OE methods, practices and tools.

Commitment Tracking:

• Issues reports of trends and overdue commitments to the Quality Council or Weekly cGMP Meeting and makes recommendations for improvement plans. Tracks and follows through on commitments made as a result of the QARs.

BASIC QUALIFICATIONS

Bachelor's degree in science or Engineering with 5-7 years of experience in the pharmaceutical industry working with manufacturing investigations and/or regulatory issues. Strong background and knowledge in manufacturing, compliance and technology investigations, processes and systems; or master's degree in science or Engineering with 3-5 years of experience in the pharmaceutical industry working with manufacturing investigations and/or regulatory issues

Technical Skills Requirements: Strong background in Manufacturing, Technical Services, Materials Management, QA/QC and Engineering is highly desirable. Self-starter, team player, with strong interpersonal and coaching skills. Excellent written skills in English. Good verbal communication and ability to coach and provide guidance to others. Computer literate, with superior skills in managing Excel spreadsheets (or similar database). Strong presentation skills. Proven record of problem-solving, decision-making skills and application of process improvement tools.

Position requires regular onsite attendance - this position may be performed on a remote or telecommute basis or a temporary or short-term basis with the ability to be onsite, when needed.

Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

Must have the ability to work effectively under and manage to strict production, time and performance deadlines.

Might require working on weekend or holidays to support Audits, work off shifts only when needed.

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