Head Analytical Laboratory

• USA
• Philadelphia, PA
• Posted 2 years ago

Globyz

Position Description

To perform the Quality Assurance and Regulatory duties for the drug products distributed by Globyz Pharma. Reporting to Vice President of Quality and Regulatory Affairs, you will be responsible for performing the day to day activities for the inspection and release of drug products and Controlled drug products, received at Globyz Pharma. You will ensure that SOP procedures are implemented and followed at Globyz pharma for the product receipt, storage, inspection and shipping. Review the data and ensure that product storage environments are controlled and maintained for the storage of drug products as per manufacturer’s instructions at Globyz facility.

The focus will be to ensure that documentation for the Quality systems (Deviation, Change Controls Customer Complaints), SOP revision and training are completed in timely fashion as per Globyz polices and meet regulatory requirements.

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

Qualified Person (QP)

• 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

Critical Competencies

• Some knowledge in Pharmaceutical Quality Assurance, Quality Compliance and Quality Systems
• Product disposition upon the quality inspection; Release or
• Ability to identify gaps or non-conformances in procedures and documentations upon
• Hand on experience in handling of deviation, CAPA, change controls and customer
• 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 and
• Active listener and willing to work as a team

Decision Making Authority

• Product disposition, to release or reject product lots based on review of the technical documentation, regulatory compliance and with the support of quality
• Identification, evaluation of deviations, leading investigations with a focus on problem solving to prevent future occurrences and to ensure the release of quality product by Globyz Pharma for customer use.
• Ability to audit GMP activities to ensure GMP
• Ability to Identify the gaps and non-conformances against current regulations and Globyz

Education And Experience

• 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

Please email your resume to [email protected]

To apply for this job email your details to [email protected].