Globyz Biopharma Services · 1 month ago
ASSOCIATE QUALITY ASSURANCE REGULATORY AFFAIRS
Boothwyn, PA
Full-time
Onsite
New Grad, Entry LevelGlobyz Biopharma Services is focused on ensuring the quality and regulatory compliance of drug products. The Associate Quality Assurance Regulatory Affairs role involves daily quality inspection and release of products, maintaining documentation, and participating in quality systems processes.
BiotechnologyClinical TrialsLife SciencePharmaceutical
Responsibilities
Perform the day to day activities of quality
Perform Quality Inspection and release of received goods, (products, Packaging materials) and complete GMP documents on a timely
Perform Daily Temperature Monitoring of product storage areas at Globyz Pharma and report any excursions / alarms to management and initiate investigation as per Globyz’
Print the weekly summary of Temperature data from electronic system and review and sign and file
Maintain the original approved SOP binder at Globyz Pharma and initiate the SOP review on or before its next due date as per Globyz Pharma
Maintain the training records of entire GMP staff. When applicable initiate the training of new and / or revised
Participate in the Quality systems; deviation, change controls and customer complaints processes. Participate in investigation and complete reports in timely
Participate in self inspection program and document the observations and follow up of
Perform periodic review of completed logs of PEST Control, Cleaning and
Coordinate, improve and sustain the activities in the quality department with all departments at Globyz
Provide support to Quality management during any product
Work with the VP Quality and Regulatory Affairs Director with a focus on process improvements in the quality
Liaison with customers, suppliers, partners and other Globyz Pharma departments
Perform QP duties as per regulations and guidance
Liaison with DEA for Controlled
Maintain Controlled Substance licenses
Report any theft or missing narcotic units to management and DEA
Where applicable, prepare application and apply for the import and export
Taking care of Controlled drug Safe at Globyz Pharma and ensure the security during handling Narcotics and Controlled drugs as per established procedures
Qualification
Required
University degree or College diploma in Life sciences
Some background in Pharmaceutical
Some knowledge of Health Canada GMPs and quality regulation during transportation and storage of drug products and handling of Controlled drug
Some knowledge in Pharmaceutical Quality Assurance, Quality Compliance and Quality Systems
Product disposition upon the quality inspection; Release or Reject
Ability to identify gaps or non-conformances in procedures and documentations
Hand on experience in handling of deviation, CAPA, change controls and customer complaints
Knowledge and experience in processes and continuous improvements
Strong interpersonal and communication skills (written and oral)
High proficiency with MS Office applications (Excel, Word, PowerPoint), email
Active listener and willing to work as a team
Company
Globyz Biopharma Services
GLOBYZ BioPharma Services is a Clinical Trials Material Supply & Specialty Medicines Distribution experts serving major markets across the world with an extensive customer base of pharmaceutical & biotech companies, CROs and clinical trial packaging companies Our Network: With offices and state of the art GMP compliant warehouses & depots in major cities, we have presence in major markets across the globe -Clinical Trial Supply Management: Global sourcing & supply of Biosimilar samples, Comparators /Reference Drugs and ancillaries, GMP Storage, temperature control transportation/distribution, packaging/labelling, depot services, IOR, QP Release, Narcotics etc.
Founded in 2007
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Salman Pathan
Founder & CEO
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