Senior Quality Site Specialist - Specialty Pharmacy

Reporting to the Director Quality, Biopharma & Provider Solutions, the Senior Specialist Quality (SSQ), will be responsible for ensuring product or service meets the established standards of quality including reliability,usability and performance.

The incumbent will support the SPS businesses at a regional and / or national level in assurance activities associated with but not limited to equipment validation, temperature monitoring, mapping, compliance with standard operating procedures (SOPs), and compliance with all

Health Canada regulations and associated laws.

At this level, the Senior Specialist Quality typically :

Acts as a key contributor in a more complex / critical environment.

Acts as a resource for colleagues with less experience; may direct the work of others without formal management responsibilities;

may utilize internal or external resources to accomplish goals

Develops resolutions to complex problems that require the frequent use of creativity.

Uses judgement within broadly defined policies and practices.

Anticipates change and directs or redirects efforts.

Accomplishes work without considerable direction and exerts significant latitude in determining objectives of assignment.

Anticipates change and communicates with management pre-identified potential solutions

Interacts with senior management and senior customer personnel on matters requiring coordination across organizational lines.

Represents the department on projects and may perform in a project leadership role

Specific Responsibilities :

Maintain an adequate level of compliance of the temperature monitoring / pressure program at SPS at a local and national level

Perform and / or manage :

The execution of the different mapping, equipment qualification,

Vaisala installation and programming protocols

Annual probe swap

Verification of the calibration certificates

Acknowledgement of alarms in Vaisala

Deviation writing and problem-solving regarding temperature excursion / system issues

Temperature trending

Maintain the outbound qualification program in SPS facilities at a local and national level

Support pharmacies in identifying the appropriate coldchain and ambient packouts

Execute / manage the qualification of the required coldchain and ambient packouts as per protocols

Perform / manage the routine packout testings as required as per protocols

Deviation writing and problem solving in regard to temperature excursion / packout issues

Track and document the change control related to the temperature management program (packouts, equipments, room)

Support the sites remotely or on site within short term notice as required (10% travelling required)

Act as a leader in identifying and / or implementing solutions linked to warehouse and distribution validation activities in collaboration with management, other QSSs and relevant internal and external stakeholders.

Support or lead site quality assessment / self-inspections / client audit as required

Support site in preparation for audits / inspection

National communication of regulatory requirements and / or changes and works closely with the sites to ensure proper dissemination.

Create and dispense training material on Quality topics for a broad range of pre-identified departments

Draft and lead the revision of quality assurance policies and procedures

Support in the interpretation and implementation of the quality assurance standards at a regional and / or national level

Evaluate adequacy of quality assurance standards at a regional and / or national level

Write, review or approve Quality documentation as required (such as but not limited to change controls, deviation report, investigations, validation reports, trend analysis reports)

Collect and compile statistical quality data

Analyze data to identify areas for improvement in the quality system

Prepare reports to communicate outcomes of quality activities Coordinate or support on-site audits conducted by external providers

Evaluate audit findings, identify risks and implement appropriate corrective actions at a regional and / or national level

Assure ongoing compliance with quality and industry regulatory requirements in regard to validation and temperature monitoring.

General Responsibilities :

Support the pharmacy sites in all areas related to temperature monitoring program

Promotes understanding of quality standards and processes with the national pharmacy network.

Identify training needs at a national and interdepartmental level and organize training interventions to meet quality standards

Support pharmacy sites in the preparation, execution and follow-up of inspections by maintaining the inspection file, managing audit documents and response actions.

Key Requirements

B.SC. in Chemistry, Biology or equivalent experience or in a related field.

Knowledge of Canadian drug GMP environment and other applicable regulations pertaining to DIN products, narcotics and precursors.

Experience in Quality investigations, inspection, auditing and testing Experience with implementation qualification and validation program Experience in validation, qualifying and temperature monitoring program

Strong computer skills including Microsoft Office, QA applications and databases Knowledge of tools, concepts and methodologies of QA

Knowledge of cold chain shipping requirements.

Knowledge of regulations and guidelines for temperature control of drug products during storage and transportation.

5 years of work experience in pharmaceutical industry in Quality Assurance

3 years Experience with equipment qualification / computer system validation (CSV) across GXP landscape

Demonstrate strong leadership in a professional environment

Ability to motivate in a teamwork environment

Excellent communication skills - verbal and written

Data collection, management and analysis

Problem analysis and problem solving

Good judgment and decision making

Customer service-oriented

Capacity to work without considerable direction

Ability to manage time and prioritize tasks is an essential characteristic

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets.

In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

For more information regarding benefits at McKesson, please

Our Base Pay Range for this position

$86,600 - $144,300