Principal Quality Assurance Compliance Specialist

6 days ago

Bethlehem, Pennsylvania, United States Piramal Group Full time
Job Title: Principal Quality Assurance Compliance Specialist

Job Summary:

The Principal Quality Assurance Compliance Specialist will be responsible for ensuring that all computerized systems meet the 21 CFR Part 11, EU Annex 11, and GAMP5 guidelines requirements. This includes performing, reviewing, and approving computerized system validation life cycle deliverables, as well as implementing and complying with data integrity at the site as the Data Integrity Compliance Officer.

Key Responsibilities:

  • Ensure all computerized systems meet the 21 CFR Part 11, EU Annex 11, and GAMP5 guidelines requirements.
  • Perform, review, and approve computerized system validation life cycle deliverables.
  • Implement and comply with data integrity at the site as the Data Integrity Compliance Officer.
  • Implement a regimen of data integrity checks on the shop floor and update the Data Integrity Risk Assessment (DIRA).
  • Handle and comply with SOPs related to data integrity and IT systems.
  • Review and conduct investigations related to data integrity, computerized systems, and engineering departments as applicable.
  • Coordinate data integrity and IT-systems projects with stakeholders at the site and corporate.
  • Handle and participate in internal and data integrity audits.
  • Involve in the selection of data integrity (DI) champions and impart necessary training to the DI champions.
  • Review change controls, deviations, CAPA, and other QMS tools.
  • Review periodic review reports.
  • Participate in supplier assessments for computerized systems, instruments, and equipment.
  • Review and approve schedules of data backup and restoration, time synchronization, etc.
  • Audit trail reports review of computerized systems.
  • Review and ensure compliance of user management activities of computerized systems.
  • Prepare and review quality risk assessments, including part 11 compliance and data integrity.
  • Review qualification documents of manufacturing equipment, facilities, utilities, and associated ancillary systems.
  • CAPA effectiveness verification.
  • GMP compliance verification for manufacturing equipment areas, utilities, and testing instruments.
  • Review software application qualifications.
  • Comply with SHE guidelines, SHE rules, and regulations, as well as PPE usage.
  • Observe non-compliant acts and conditions and take corrective and preventive actions immediately, as necessary.
  • Report any incidents/accidents/near misses/illness to superiors.
  • Follow company quality procedures, standards, and specifications.
  • Perform other jobs as assigned by the HOD.
  • Responsible for the work of seniors in their absence.

Requirements:

  • Bachelor's degree in a relevant scientific quality assurance or technical field.
  • 5+ years of experience.
  • Strong understanding of pharmaceutical cGMP, industry standards, and regulations.
  • Excellent verbal and written communication skills.
  • Expert-level user of quality computer systems.
  • Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems.
  • Thorough understanding of computer system validation and GAMP requirements.
  • Ability to analyze data/trends to make sound regulatory interpretations while preparing metrics and reports.
  • Ability to drive projects related to the implementation of new workflows and updates to new systems.

About Us:

Piramal Group is a global organization with a presence in over 100 countries. We are committed to delivering critical care solutions for patients and healthcare providers across the globe. Our rich product portfolio includes inhalation anaesthetics, intrathecal baclofen therapy, and other critical care solutions. We have wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA, and other regulators.

Equal Employment Opportunity:

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based on race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit, considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation, and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

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