Jennifer S. Email & Phone Number

Denmark

• Establish new, ground-breaking biotech facilities and factories utilizing modern technology with fully automated operations and digitalised processes across the world.• Participate as part of the global project team in delivering best-in-class quality for qualification of pharmaceutical aseptic facility, equipment, and processes according to science and risk-based validation principles.• Challenge and set direction for quality assurance for one or more aseptic production processes (handling of incoming raw materials and components, wash and sterilization, formulation, filling, and final inspection of the products).• Approve documentation and conduct Quality Assurance oversight.

Vancouver, British Columbia, Canada

- Small business owner and run daily administration for business such as timely communication with clients, accounting such as invoicing, email correspondence, business marketing and social media.- Provide photo session pre-consultation as required, budget planning, location(s) scouting.- Provide complimentary ‘no charge’ photography services to non-profit organizations, low income families and to help fundraise for charity such as donating photography services.- Conduct in a professional manner when dealing with clients and ensure delivery of high quality digital images to clients in a timely manner.- Specialize in ‘people’ photography such as events, headshots and family.

- Oversee the Quality Program as it pertains ot the GxP environment for pharmaceuticals and (limited) medical devices including: Validation/Calibration, Documentation, Training, Facility Monitoring, internal and External Audits.- Responsible for primary batch review for all imported products, technical and quality agreements and quality control releases.- Spearhead continuous quality improvement activities and oversee the content, coordination, validation and execution of the electronic Quality Management System (eQMS). - Coordinate external audits, internal audits, and gap analysis and liaise with external quality and service vendors about quality matters.- Manage strategic/compliance risk assessments, facilitate root cause analysis and CAPA process implementation and effectiveness checks.- Annual product quality review, vendor and internal quality audit programs- Electronic/digital signature implementation and compliance (FDA 21 CFR Part 11 requirement)

Vancouver, British Columbia, Canada

- Develop, implement, and maintain all PQS related activities and processes to ensure compliance in accordance with cGxP.- Participate in writing or revision to controlled documents (e.g., SOPs, Specifications, Methods, Batch Records etc.)- Conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.- Interfaces with contract manufacturers to address documentation and compliance issues.- Collabrate with Formulation (Research and Development), Quality Control, Manufacturing/Operation, Project Management team to bring the Covid-19 vaccine program from concept to manufacture.- Provide GxP training to personnel. - Assisted in ISO 9001:2015 certification process such as participation in audit and draft SOPs in collaboration with department subject matter experts (SMEs)

Mission, British Columbia, Canada

- Health Canada Security Clearance Issued Nov 2020, Expires Nov 2025- Establish, develop and implement all quality and Good Production Practices (GPP) systems, the Quality Management System and Sanitization program.- Ensure appropriate compliance to all relevant regulatory requirements associated with the manufacturing, testing, packaging, storage and testing of products.- Approve / reject starting materials, packaging materials, intermediate, bulk and finished products.- Continually monitor GPP regulatory requirements under the Cannabis Regulations/Act and any associated regulations such as Safe Food for Canadians Regulations (SFCR), HACCP.- Manage the qualification and approval of vendors, contractors, and contract labs as required.- Prepare and submit Health Canada regulatory documentation requirements to obtain licencse approval.

Burnaby, British Columbia, Canada

- Provide one-on-one visits interacting with senior residents.- Assist Recreation staff in setting up a variety of recreation programs such as knitting, baking, sports, music and entertainment sessions.- Escort residents to and from indoor and outdoor programs and socialize with residents during programs.

Burnaby, B.C,

- Implement, monitor effectiveness, maintain and manage the CAPA system by auditing, following up on assigned CAPA.- Conduct investigations associated with non-conformances through root cause analysis, summarize findings, and recommend corrective actions.- Conduct timely review of batch records and resolve any issues with the contract manufacturers ready for product disposition final approval.- Act as 'Runner' for timely and accurate retreival of requested documentations during FDA on-site inspection.

Edmonton, Alberta, Canada

- Recruit and schedule subjects as per requirements in protocol into clinical studies, maintain and update subject records database using Microsoft Access.- Ensure confidentiality of all subject records and recommend clinical file updates as required and liaise with medical staff (Study Physicians, Registered Nurses) as needed.- Collate raw data generated from subjects during clinical studies into a central filing system and create new subject files, update and maintain existing subjects files as required.- Perform all duties in accordance with GLP standards and maintain training in GLP and SOP requirements and maintain laboratory records in accordance with SOP and specific study requirements.- Prepare calibration standards, quality control and clinical study samples for routine sample analysis and operate equipment, including Gas Chromatography Spectrometer etc.- Assist in maintaining GLP compliance by participating in routine laboratory quality assurance duties such as maintaining inventories, updating equipment logs, performing routine calibration checks- Conduct mini validations to improve existing analytical methods and analyze analytical results.

Edmonton, Canada Area

-Manage the system for change controlled documents and controlled records, as well as being closely involved in the drafting and approval of new documentation for the quality system.- Identify quality training needs and assists in developing and conducting training sessions for staff.- Create, implement and maintain QMS electronic and hard copy documents in compliance with GMP requirements accurately in a state of daily audits.- Edit and create Master Documents for in-house documents to ensure documents meet new campaign requirements in an organized and timely manner with Quality Assurance Manager.- Interact with Originators, Reviewers, and Quality Assurance Manager for approval of official controlled documents.- Update and maintain Control Forms and in-house labels in the most current version and reconcile issuance of Control Forms used in Batch Production Records and report any and all discrepancies to Quality Assurance Manager in a timely manner.