Job Quality and Compliance Specialist in Aurora

Quality and Compliance Specialist

Aurora
Job description

JOB PURPOSE:

Provide assurance that all data generated from the analytical laboratories AS are accurate, complete and in compliance with data integrity, current Good Manufacturing Practices (CGMP), clients and regulatory agency requirements. Maintains quality and compliance by identifying quality requirements, disseminating standards, policies, and procedures and recommending improvement plans.

JOB RESPONSIBILITIES:

  • Review all analytical data generated by the analytical laboratories including but not limited toraw and packaging materials, product contact materials, in-process controls, cleaning verifications, products, method validations, method transfers, stability studies, standard qualifications, batch release, R&D samples (as applicable) and any third party samples for accuracy, completeness and compliance to data integrity, written procedures and CGMP regulations
  • Review all planned and unplanned deviations for accuracy, completeness and compliance to data integrity, written procedures and CGMP regulations
  • Release of starting materials (raw materials, packaging and product contact materials) for GMP manufacturing
  • TIMS release of all tests and samples listed above · Issue deviations numbers, as applicable
  • Review lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports
  • Ensure compliance with internal approved procedures, specifications and protocols of all generated data
  • Ensure timely completion of all data review
  • Filing of request forms, runlogs, lab numbers and other lab documentation, as required
  • Review out-of-specifications, analytical deviations, investigations and run log summaries
  • Maintain accurate impurity profiles for all manufactured batches including intermediates and finished products
  • Perform initial review of research and pilot specifications versus raw data from method development, representative R&D samples and first batch introductions and inform the AS Manager of any required changes to specifications
  • Create and revise Certificates of Analysis and other technical documents as required
  • Revise via change control documentation as required
  • Participate in the implementation of continuous improvement initiatives as they relate to quality activities (e.g., introduction of new technology and automation with respect to data acquisition, electronic review, quality management systems, LIMS, etc.)
  • Participate in internal and external audits
  • Provide data and information pertaining to lab or systems for internal or external clients as requested Perform other related assignments and projects as required

JOB REQUIREMENTS:

EDUCATIONAL AND PROFESSIONAL ATTAINMENT

B.Sc. degree in Chemistry or related science

JOB RELATED WORK EXPERIENCE REQUIRED

2 years related experience and within the pharmaceutical industry preferred.

Commensurate with education (approx. 2 or more yrs. with B.Sc.; approx. 5 or more yrs. with post-secondary school education)

Knowledge of relevant regulations and guidances required to ensure site compliance

Knowledge of relevant regulations and guidances required to ensure site compliance

SKILLS AND KNOWLEDGE

  • Good knowledge of CGMP requirements, ICH, FDA guidelines · Knowledge of analytical instrumentation and techniques
  • Skills in interpreting and trending analytical data and instrumentation/equipment software (Empower and stand alone instruments)
  • Understanding of method development, validation, transfer and stability requirements
  • Strong software application skills including word processing, spreadsheets and databases
  • Strong communication skills, both written and verbal Extensive knowledge of compliance in the pharmaceutical manufacturing processes (API)

CRITICAL ATTRIBUTES

  • EHS Focus
  • Passionately Reliable
  • Rapid Responsiveness
  • Innovative Efficiency
  • Teamwork
  • Detail Orientation

Piramal Pharma Solutions is an equal opportunity employer. We prohibit discrimination based on age, color, disability, national origin, race, religion, sex, sexual orientation, and any other legally protected class in accordance with applicable federal, provincial and local laws. We are also committed to creating and maintaining an inclusive and accessible workplace. If you are contacted to be part of our recruitment process and require accommodation during it, please let us know.

#INDHP

Job Type: Full-time

Flexible Language Requirement:

  • English not required

Schedule:

  • 8 hour shift

COVID-19 considerations:
Strong COVID response plan including, masking, barriers, sanitizers and disinfectants, enforced physical distancing and enhanced PPE where distance cannot be maintained, temperature checking, employee and visitor screening, contact tracing, open comms

Ability to commute/relocate:

  • Aurora, ON: reliably commute or plan to relocate before starting work (required)
Job Quality and Compliance Specialist in Aurora

Piramal Enterprises

Aurora