QA Release Specialist

3 weeks ago

Milton, Canada Cencora Full time

- What you will be doing
PRIMARY DUTIES AND RESPONSIBILITIES:_- Product Release Management: Receipt, inspection and release of client specific products to market. Perform timely review and assessment of documents received from clients/foreign sites, including but not limited to, manufacturing and packaging records, Certificates of Analysis, Certificates of Manufacture, and other product release documents. Perform quality and regulatory reviews and oversight on imported products as assigned making quality decisions and addressing or resolving problems based on analysis and consultation with clients. Communication of batch status and issues effectively to all levels of the organization as well as supply chain.- Support Product Launch activities: Coordinate with clients and/or foreign sites or other internal departments with launch activities, the compilation of complete GMP Quality documents to support the importation of client products. Provide Quality Assurance guidance and support to potential new clients or new products as assigned.- Management of Customer complaints: receipt and triage of customer complaints, analyzes customer complaints and identifies trends and tendencies with respect to lot, product, and type of complaint and determines the cause; drafts complaint reports; recommends changes based on investigations and trend analyses- Maintenance of Master documents: Coordinate with clients and/or foreign sites for the receipt, review and updates to master documents to ensure compliance to GMPs and in relation to product release activities.- Maintenance of GMP Documentation: Maintain and review in-house and client-based quality documents such as APQR, stability reports, equipment and facility qualification/validation protocols and reports, product label, temperature study etc. Sustain an effective system for maintaining copies of documents received from clients/foreign sites as well as those submitted to Health Canada, allowing ease of location and retrieval of records.- Management and control of changes: supports the initiation of change requests for equipment, primary and secondary components, processes, systems and documentation; monitors follow-up with parties involved; ensures that deliverables are compliant pursuant to the change; closes changes upon implementation. Management of trend reporting for changes.- Deviation/Non
- Conformance Investigations: Investigate and document any discrepancies recorded during product handling and ensure product disposition decisions are made in conjunction with client and GMP regulations.- Involved in activities geared towards process and or document improvements: Support the QA department in ensuring Innomar GMP facilities operate and are in compliance with Good Manufacturing Practices and applicable Health Canada regulations at all times which may include review and approval of quality failures and non-compliance investigations; perform follow-up on corrective and preventive actions pursuant to an incidents; assist with process optimization; review of standard operating procedures; assist with internal and external audits.- Inspections: Provide support during audits/inspections by internal, client, third party or regulatory bodies.- Recall Management: provide support to the Senior Manager, QA for Product Recalls, including customer notification, coordination of customer returns and maintaining documentation.- AQPIC Activities: Assist the QPIC in the maintenance of standard operating procedures (SOPs) in compliance with Health Canada regulations. Assist the QPIC in ensuring that Innomar operates and is in compliance with the Narcotic Control Regulations as set out by Health Canada. Assist the QPIC to ensure that all transactions occurring at the respective distribution centre are in compliance with Innomar SOP’s relevant to the Narcotic, Precursor, and GMPs, including but not limited to Shipping, Receiving, Returns, Pick & Pack, Inventory Control, Credits, Security/Maintenance, Government Reporting, Record Maintenance, Destruction and Government reporting. Assist the QPIC in providing the Senior Manager, QA with any reporting to Government, regarding narcotic discrepancies and other required reports. Act as the back up to the QPIC.- Support Quality Organization: Provide assistance to the QA Senior Manager Quality Assurance as required. Performs other projects as assignedMay be required to be on standby/ on call as part of this role.
What your background should look like
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:_Bachelor of Science degree requiredMinimum of 3-5 years’ experience in GMP Quality Assurance/Quality Control/ComplianceDirect pharmaceutical Quality Assurance/Quality Control/Compliance experienceRegulatory Affairs or Quality Assurance Certification as asset
- MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:_Must have full and complete knowledge of the Good Manufacturing Practices and applicable Health Canada regulations and guidelines (i.e., Dr

  • QA Release Specialist

    1 week ago

    Milton, Ontario, Canada Innomar Strategies Inc. Full time

    QA Release Specialist (12 Month Contract) page is loaded QA Release Specialist (12 Month Contract) Apply locations Milton, ON time type Full time posted on Posted Yesterday job requisition id R242324 Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is...

  • QA Release Specialist

    1 week ago

    Milton, Ontario, Canada Innomar Strategies Full time

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...

  • QA Release Specialist

    1 month ago

    Milton, Canada Innomar Strategies Full time

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...

  • QA Release Specialist

    3 weeks ago

    Milton, Canada Innomar Strategies Full time

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...

  • Quality Specialist

    3 days ago

    Milton, Canada McKesson Full time

    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a...

  • QA Compliance Specialist

    2 months ago

    Milton, Canada AmerisourceBergen Full time

    - What you will be doing PRIMARY DUTIES AND RESPONSIBILITIES:_- Management of Stability Program: obtain and review stability studies, confirms product expiry terms based on data analyses and confirm stability of product on the market- Management of the Annual Product Quality Report Program: support the APQR program by obtaining and reviewing documents...

  • QA Compliance Specialist

    3 weeks ago

    Milton, Canada Cencora Full time

    - What you will be doing PRIMARY DUTIES AND RESPONSIBILITIES:_- Management of Stability Program: obtain and review stability studies, confirms product expiry terms based on data analyses and confirm stability of product on the market- Management of the Annual Product Quality Report Program: support the APQR program by obtaining and reviewing documents...

  • Senior Specialist, Quality Assurance

    1 week ago

    Milton, Ontario, Canada Innomar Strategies Inc. Full time

    QA Release Specialist (12 Month Contract) page is loaded QA Release Specialist (12 Month Contract) Apply locations Milton, ON time type Full time posted on Posted Yesterday job requisition id R242324 Our team members are at the heart of everything we do. If you want to make a difference at the center of health, come join our innovative company and help us...

  • 3pl Quality Assurance Specialist

    4 weeks ago

    Milton, Canada McKesson Full time

    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a...

  • Customs Specialist

    2 weeks ago

    Milton, Canada DSV Full time

    If you are a current DSV employee and interested in a position in another country,please contact your Human Resource representative to discuss the process and requirements of applying. - Job area: Customs**DSV - Global Transport and Logistics** Location: CAN - Milton, Yukon Court Job Posting Title: Customs Specialist Time Type: Full Time SUMMARY Primary...

  • Customs Specialist

    4 weeks ago

    Milton, Ontario, Canada DSV Global Transport & Logistics Full time

    DSV - Global Transport and Logistics DSV encourages inclusivity and are committed to diversity in the workplace while welcoming applications from all qualified individuals including women, members of visible minorities, aboriginal persons, and persons with disabilities. Our goal is to provide an inclusive environment for all to succeed. We work with...

  • Customs Specialist

    2 months ago

    Milton, Ontario, Canada DSV Global Transport & Logistics Full time

    DSV - Global Transport and Logistics DSV encourages inclusivity and are committed to diversity in the workplace while welcoming applications from all qualified individuals including women, members of visible minorities, aboriginal persons, and persons with disabilities. Our goal is to provide an inclusive environment for all to succeed. We work with...

  • Specialist, Quality Assurance

    4 weeks ago

    Milton, Canada Fresh Start Foods Full time

    Fresh Start Foods Canada Ltd. - Join one of the BEST teams in the Industry - At Fresh Start Foods you'll find qualified professionals that stand out with their experience and understand that customers are at the centre of everything we do.- We are seeking individuals: - Who are customer centric - Who are able to deliver on their commitments - Who value...

  • Specialist, Quality Assurance

    4 weeks ago

    Milton, Canada Fresh Start Foods Full time

    Fresh Start Foods Canada Ltd. Join one of the BEST teams in the Industry At Fresh Start Foods you'll find qualified professionals that stand out with their experience and understand that customers are at the centre of everything we do. We are seeking individuals: - Who are customer centric - Who are able to deliver on their commitments - Who value...

  • Specialist, Credit Customer Care

    2 weeks ago

    Milton, Canada SYSCO FOOD SERVICES Full time

    **Specialist, Credit Customer Care (Bilingual - Eng & French)** - Reports To Manager, Customer Care Center of Excellence Location Remote Type Full time, Permanent Closing Date June 28th, 2024 **Company Overview** Sysco connects the world to share food and care for one another. Sysco leads from the heart of food and service to deliver the freshest of...

  • Order Management Specialist

    2 weeks ago

    Milton, Canada Eaton Full time

    **Eaton’s Electrical sector is currently hiring a Order Management Specialist to join our team. This position is based at our Milton, ON facility and offers benefits from Day 1.** **What you’ll do**: Reporting to the Operations Manager, the Order Management Specialist is responsible to proactively manage Milton’s manufacturing plant orders containing...

  • Specialist, Credit Customer Care

    1 week ago

    Milton, Ontario, Canada SYSCO FOOD SERVICES Full time

    Specialist, Credit Customer Care (Bilingual - Eng & French) Reports ToManager, Customer Care Center of ExcellenceLocationRemoteTypeFull time, PermanentClosing DateJune 28th, 2024Company OverviewSysco connects the world to share food and care for one another. Sysco leads from the heart of food and service to deliver the freshest of foods and ideas to...

  • Customer Care Process Specialist, Mckesson

    1 week ago

    Milton, Canada McKesson Canada Full time

    McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Canada, we touch the lives of 12 million Canadians every day. We carry more than 35,000 products in 12 distribution centers and ultimately provide distribution to 6,300 retail pharmacies, 1,350 hospitals, long-term care...

  • Intern - Msd Quality

    4 weeks ago

    Milton, Canada McKesson Full time

    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a...

  • Intern - Msd Quality

    3 days ago

    Milton, Canada McKesson Full time

    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a...