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Patheon
Data Integrity Compliance Officer
Greenville, SC - USA
Posted April 19, 2017

Join us as We Transform How Pharmaceuticals are Made.

Patheon is looking for people who are passionate about making a difference in people’s lives. Patheon is in need of proven leaders to nurture talent, build effective teams and drive engagement in an environment where people are motivated to do their best for the company, its clients and their patients. To inspire collaboration and innovation.
Summary

Ensures laboratories are in compliance with industry regulations, corporate data integrity standards, documentation practices and procedures as related to both paper and electronic records.   Leads a team to ensure quality data reporting for the department and site.

Key Requirements

 

  1. Provides leadership to assigned staff by performing the following:  leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed; meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

     

  2. Ensures data integrity practices and procedures are implemented and adhered to for quality compliance and to meet industry standards. Establishes operational objectives and assists with developing, modifying and executing company policies.

     

  3. Ensures all new and existing equipment is assessed appropriately and validated for its intended use and existence. Coordinates procedure/process testing and provides reviews of audit trails.

 

  1.  Provides gap assessments and status updates to senior management to maintain and improve data integrity.

     

  2. Performs risk assessments to determine high risk equipment and determines appropriate corrective action.

     

  3. Leads departmental data integrity training for all lab / production operations, ensuring awareness and compliance with data integrity for both paper and electronic records.  Ensures appropriate inspector interactions and good documentation practices.

     

  4. Develops, manages, and updates procedures as necessary to ensure there is clear direction and understanding regarding awareness, responsibilities and the importance of corporate and regulatory requirements for data integrity compliance.

     

  5. Creates and executes change controls and establishes user requirements for laboratory and operations equipment.

     

  6. Ensures all software used for the generation of current Good Manufacturing Practices (cGMP) meets the standards required for data integrity compliance.

     

  7. Leads and establishes, where necessary, a surveillance program to audit all laboratory and operational practices and staff for compliance with established documentation and data integrity standards, practices and procedures.

 

Job Scope:

Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.

 

Supervision:

Manages the coordination of the activities of a section or department with responsibility for results.

 

Qualifications

Education:

Bachelor’s Degree in chemical or biological sciences or related field.

Experience:

Seven years experience in a regulated industry or 5 years with related technical knowledge including data integrity related to quality control data from chromatographic systems.  Experience with laboratory metrology and instrumentation compliance. Project Management and/or  prior management experience preferred.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies: 

Strong knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).  Expert knowledge of laboratory instrumentation and/or operations equipment.     Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).  Effective written, interpersonal, and presentation skills.  Ability to work on multiple projects simultaneously.  Ability to drive functional, technical and operational excellence. Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.

 

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

 

Disclaimer: 

This job description is intended to present the general content and requirements for the performance of this job.  The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

 

Nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

 

 

Help Us Make a Healthier World.

Patheon provides development and manufacturing services for more than 800 pharmaceuticals, including nearly a fifth of the world’s top selling drugs. We’ve helped our clients earn more than twice as many U.S. FDA approvals than any other CDMO. Are you as committed as we are to exceeding expectations with high-quality solutions to complex problems? If so, we want to talk to you about making a healthier world... together. Join us at patheon.com
Disclaimer

Patheon is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 
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