Computer System Validation (CSV) Compliance Specialist - Data Integrity Job at SK Pharmteco, King of Prussia, PA

YTdxSUxJbnBGUTlEbmQ1bEhrZ2tiS0xYNFE9PQ==
  • SK Pharmteco
  • King of Prussia, PA

Job Description

Company Overview:
SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide - Korea, France, Ireland, and the United States (CA and PA). Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of small molecule APIs and intermediates, viral vectors for gene therapies, cell therapies, registered starting materials, and analytical services for the pharmaceutical industry worldwide.

Position Summary:
The Computer System Validation (CSV) Compliance Specialist – Data Integrity will be responsible for executing validation activities for computer systems and software applications, ensuring compliance with regulatory requirements, industry standards, and company policies. This role involves completing periodic reviews for all GMP systems.
This position is based onsite in King of Prussia, PA.

Primary  Responsibilities:
  • Execute CSV activities in accordance with regulatory requirements (e.g., FDA, EMA, GxP) and industry standards (e.g., GAMP 5).
  • Prepare and review validation documentation to ensure data accuracy, consistency, and reliability within an organizations database systems and processes.
  • Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure the life of computerized system remains in a validated state, complies with current regulatory requirements, is fit for intended use, and satisfies company policies and procedures.
  • Identify and troubleshoot validation issues, providing technical support and recommendations for resolution.
  • Maintain accurate and complete validation records and documentation.
  • Support the CSV Manager in planning and coordinating validation projects to ensure timely completion and adherence to project timelines.
  • Participate in continuous improvement initiatives to enhance the CSV process.
Skills and Qualifications:
  • Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related field.
  • 1-3 years of experience in computer system validation within the pharmaceutical, biotechnology, medical device, or related industry.
  • Knowledge of regulatory requirements and industry standards related to CSV (e.g., FDA 21 CFR Part 11, GAMP 5, EU Annex 11).
  • Excellent analytical and problem-solving skills, with a keen attention to detail.
  • Effective communication and interpersonal skills, with the ability to collaborate and build relationships with cross-functional teams.
  • Ability to manage multiple tasks simultaneously and meet deadlines.
  • Ability to work independently and as part of a team, with a proactive and results-oriented approach.

Physical Requirements:

  • Ability to sit for periods of time viewing a computer workstation

Note: This job description is intended to convey information essential to understanding the scope of the job role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.

SK pharmteco Inc., is an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.

 

Job Tags

Full time, Contract work, Worldwide,

Similar Jobs

New Beginnings Counseling Center

Finance Director Job at New Beginnings Counseling Center

 ...join our team as Finance Director. Under general direction of the Executive Director, the Finance Director will work to manage all...  ...reporting. Manage the organization's cash flow, investments, and banking relationships. Ensure compliance with nonprofit accounting... 

Seton Education Partners

Data Systems Administrator Job at Seton Education Partners

 ...Data Systems Administrator Bronx, NY Seton Education Partners seeks a mission-driven...  .... The Data Systems Administrator is an entry-level role crucial for managing and maintaining...  ...Strong understanding of data systems and databases Excellent problem-solving and... 

Ocean Casino Resort

Specialty Cook - Pastry Job at Ocean Casino Resort

 ...portion, cook from scratch, and present a variety of hot and/or cold food items using specialized techniques and skills for various meal...  ...standards set forth by Ocean Casino, local, state, and federal regulatory agencies. Position Responsibilities Prepares and cooks... 

XPO Logistics

Local Class A Hazmat Driver Job Job at XPO Logistics

 ...BenefitsTo apply; Please click on the link below to fill out the XPO online driver application and release forms.https://intelliapp...  ...Account.Person to Contact about this CDL Job: ChristinaXPO Logistics Phone Number: (***) ***-**** Tell em' Gary's Job Board sent you.... 

CarDon

Certified Nursing Assistant (CNA) Job at CarDon

CarDon is a family-owned senior-living company with more than 20 communities in the Midwest. We offer independent and assisted living, rehabilitation, skilled nursing and memory support. Were rapidly growing, offer a wide variety of career paths, and reward bright ideas...