Job Description

JOB PURPOSE:
Support the Company's QC/AS Laboratory to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory agencies, client and corporate expectationsJOB RESPONSIBILITIES:

• Sample management through log-in of samples, sample updates, backup reports for all required tests generated by QC/AS/AD laboratories as per internal SOPs
• Maintain accurate and current inventory of client and internal retain standards and samples (e.g., regulatory and in-house batch retains as per internal SOPs)
• Coordinate sample shipments for external testing (including follow-up as required and data reporting as required)
• Format, update, manage and scan testing specifications (e.g., conversions of pilot and red-bordered formats)
• Perform staff training (for new employees and ongoing retraining) on current database (TIMS)
• Gather, copy and scan reports generated by the QC/AS Laboratory for clients and or audits as required
• Off-site archival of documents generated by the QC/AS Laboratory (e.g. method validations, run logs, etc.)
• Maintain stability calendar and log of stability studies in each stability chamber
• Supporting the Vendor qualification program through material certification and contract lab qualifications (Quality Agreements, VQMS updates)
• Miscellaneous tasks (eg. Tax forms for Research work, Technical Reports, Work Books, Reconciliation of external testing costing in AS)
• Contribute to the continuous improvement of laboratory systems and procedures
• Promote and ensure compliance with cGMP and safe and clean lab operations

JOB REQUIREMENTS: EDUCATIONAL AND PROFESSIONAL ATTAINMENT

• Diploma or certificate in a related scientific discipline is preferred

JOB RELATED WORK EXPERIENCE REQUIRED
2 years experience in a quality and compliance and/or laboratory position, preferably within the pharmaceutical or Active Pharmaceutical Ingredients manufacturing industrySKILLS AND KNOWLEDGE

• Skills and knowledge in coordinating laboratory activities
• Good practical knowledge of cGMP
• Software application experience (e.g. word processing, spreadsheets and databases)

CRITICAL ATTRIBUTES

• E.H.S. 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.INDLPJob Type: Full-timeSchedule:

• 8 hour shift

COVID-19 considerations:
Masking, maintaining distance, contract tracing, hand sanitizer, disinfection, max room occupancy, barriers, employee and visitor screening, temperature checks and more.Ability to commute/relocate:

• Aurora, ON: reliably commute or plan to relocate before starting work (required)