Senior Specialist, Quality Assurance

Job title:

Senior Specialist, High quality Assurance

Firm

Consumers Drug Mart

Job description

Referred candidates should not apply on to this function. All referred candidates should use their distinctive referral hyperlink generated when they’re referred by an present colleague.Location: 243 Customers Street, Toronto, Ontario, M2J 4W8At Consumers Drug Mart, we’re innovating well being and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we’re caring and supporting our prospects in new methods daily.
With greater than 1,300 regionally owned and operated shops from coast to coast, the Consumers Drug Mart community is greater than an excellent place to buy, it’s an excellent place to work. We’re dedicated to constructing our gifted staff who champion collaboration, kindness and inclusivity. Be part of our staff, and assist acknowledge a wholesome future in your profession and for all Canadians.Why this function is necessary?Reporting on to Supervisor, High quality Assurance, the incumbent will probably be accountable for implementing and sustaining the High quality System on the distribution facilities guaranteeing compliance with Canadian legal guidelines and Well being Canada laws and pointers relevant to medicine, medical units and pure well being merchandise. This contains reviewing paperwork, evaluating returned merchandise, offering product disposition, creating SOPs, threat evaluation and administration, auditing, validation, change management, non-conformances, CAPAs, sustaining regulatory licenses, and so forth.Duties and Obligations:
Working intently throughout the enterprise Operations and exterior suppliers, the Sr. Specialist High quality Assurance will ship the event, implementation and upkeep of high quality programs and requirements.

• Doc/File Administration:

o Evaluate authorities, regulatory and company insurance policies to make sure all procedures are present and meet necessities
o Establish compliance gaps, develop and implement plans to handle compliance gaps
o Replace/Develop SOPs guaranteeing well timed implementation
o Keep group of all high quality paperwork

• Change Management (Inside and Exterior):

o Evaluate and course of change requests for product create/itemizing/de-listing
o Evaluate and supply high quality and regulatory impression evaluation on course of/tools/provider/ materials change requests from SDM Operations and distribution facilities
o Replace metrics

• Non-conformances/Deviations/CAPAs:

o Help the oversight of Product Quarantine/Reject course of at Distribution Facilities
o Liaise between suppliers and distribution facilities in acquiring product stability info/ evaluation from suppliers and issuing product disposition to distribution middle QA within the occasion of temperature tour impacting/doubtlessly impacting merchandise
o Write CAPAs when non-conformances happen
o Present assist by reviewing and guaranteeing well timed completion and closure of Non-conformances/ Deviations/CAPAs experiences
o Evaluate, monitor and pattern deviations/non-conformances/CAPAs

• Inside/Exterior High quality/Regulatory Audits:

o Conduct inner and exterior audits, put together report and follow-up on points recognized guaranteeing well timed and 100% completion of corrective/preventive actions
o Inside GMP Self Inspection: Audit and report on the GMP administration system to make sure its on-going efficient utility
o Help Regulatory (e.g. Well being Canada) inspections with the Supervisor QA, Director QA and Sr. Director QA
o Monitor closure of audit commitments

• Product Complaints:

o Monitor and report product complaints to suppliers and follow-up on corrections/corrective actions, as wanted
o Liaise efficient processing of complaints and return of grievance samples to suppliers, as wanted
o Talk corrections/corrective actions by provider internally and to distribution middle QA, as wanted

• Provider High quality:

o Help provider and/or materials qualification (e.g. vendor audits, institution of High quality Agreements, product overview/evaluation)
o Keep copies of present suppliers’ regulatory licenses (i.e. DEL, MDEL, Narcotic, Precursor, Approved Personnel) – annual

• Returned Merchandise:

o Consider returned merchandise and related documentations and supply product disposition

• Validation/Qualification:

o Write and execute Validation Grasp Plan and validation protocols (e.g. course of, tools, amenities, software program qualification, materials qualification, and so forth.)
o Analyze validation outcomes and write validation closing experiences
o Evaluate validation protocols and experiences
o Observe-up on completion of validation/re-validation
o Conduct seasonal transport lane temperature profile research

• Personnel Coaching:

o Conduct personnel coaching on GMPs and SOPs
o Monitor well timed completion of personnel coaching and handle personnel high quality coaching information

• Administration Evaluate Conferences:

o Report on the standing of SDM and distribution middle High quality Programs to Supervisor, QA
o Put together quarterly and annual experiences on high quality objectives and metrics
o Current and take part within the high quality administration overview conferences

• FCA/Remembers:

o Help improvement and execution of FCA/Remembers
o Present Recall report back to provider, as required
o Put together quarterly and annual experiences on high quality metrics

• Regulatory Affairs:

o Keep institution licenses issued by Well being Canada

• Venture Administration:

o Help/Lead tasks with high quality/regulatory impression
o Decide and well timed execute/implement high quality necessities per plan

• Others:

o Help of different Healthcare companies, as required
o Carry out different High quality duties, as assigned
o Occasional journey to numerous SDM/vendor websites is requiredExpertise and Expertise:
This place requires a sophisticated stage of initiative and judgment with a purpose to arrange and prioritize duties, workload and tasks. A powerful skill to affect whereas sustaining courtesy, tact and diplomacy is required in coping with colleagues in daily working relationships.

• Minimal 3 years working in GMP pharmaceutical trade in High quality Assurance
• Will need to have a Bachelor of Science (or Canadian Equal); Most well-liked – Bachelor of Science in Pharmacy
• Strong expertise in writing and conducting validation protocols
• Sturdy understanding of Well being Canada GMP and different associated pointers, Medical Gadget Rules, Pure Well being Product Rules, the Narcotic Managed Rules, Managed Medication and Substances Act, Benzodiazepine and Different Focused Substances Rules, Precursor Management Rules
• Regulatory Affairs, Provide Chain and Logistics expertise, an asset

Extra Expertise and Expertise:

• Requires a capability to use ideas and theories to enhance features or models.
• Requires specialised interpersonal expertise to resolve conditions with colleagues the place there could also be some stage of battle, stress or uncertainty.
• Supplies options through the use of imaginative approaches the place constructive and important considering and innovation are required.
• Makes use of choice making expertise to attain particular organizational goals with consideration given to their impression on different work teams.
• Adaptable to set and prioritize work with various exceptions. Capable of work with numerous personalities and types.
• Superior understanding of High quality Assurance insurance policies and procedures in a producing, provide chain/logistics setting
• Potential to deal with delicate points requiring well timed completion of documentation with a purpose to management deficiencies and expedite product inclinations
• Sound information of compliance and regulatory parts, auditing expertise, and high quality programs
• Interpret Well being Canada GMPs and different Tips and laws, PIC/s, company insurance policies/requirements to find out SDM place relating to high quality processes, compliance necessities
• Sustaining high quality and affected person security first whereas recognizing the significance of fine enterprise selections
• Laptop expertise to provide efficient experiences, paperwork, spreadsheets and shows.
• Communicates with readability, verbally to conduct personnel coaching and in a single on one or group conditions, or over the phone.
• Communicates properly in writing by composing clear paperwork
• Capable of work with minimal of supervision.
• Proficiency in SAP and all Microsoft Workplace purposes (particularly Excel, Phrase and PowerPoint)

Why work at Consumers Drug Mart?Performing as consultants, supporting inner prospects and the Affiliate-House owners, you’ll get expertise distinctive to the retail trade whereas working for an award-winning nationwide model. Profit from a purchase order low cost program, aggressive pay and on-line studying by means of Academy.Take possession of your work and discover extra methods to care about your work, co-workers, prospects and group.How You’ll Succeed:At Consumers Drug Mart Inc., we search nice individuals to repeatedly strengthen our tradition. We imagine nice individuals mannequin our values, are genuine, construct belief and make connections.If that sounds such as you, and you might be open-minded, responsive to alter and as much as the challenges supplied in a fast-paced retail setting, apply right now.Employment Kind: Full timeKind of Function: CommonConsumers Drug Mart Inc. acknowledges Canada’s range as a supply of nationwide pleasure and power. Now we have made it a precedence to replicate our nation’s evolving range within the merchandise we promote, the individuals we rent, and the tradition we create in our group. Lodging is obtainable upon request for candidates with disabilities within the recruitment and evaluation course of and when employed.As well as, we imagine that compliance with legal guidelines is about doing the precise factor. Upholding the regulation is a part of our Code of Conduct – it reinforces what our prospects and stakeholders count on of us.Please Notice: You probably have Worker Self Service (ESS) on Workday, apply to this job by way of the Workday utility.

Anticipated wage

Location

Toronto, ON

Job date

Fri, 22 Mar 2024 07:04:10 GMT

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