QA Specialist, Toronto

POINT Biopharma World Inc. is a globally targeted radiopharmaceutical firm constructing a platform for the scientific improvement and commercialization of radioligands that combat most cancers. POINT goals to remodel precision oncology by combining a portfolio of focused radioligand belongings, a seasoned administration staff, an industry-leading pipeline, in-house manufacturing capabilities, and secured provide for medical isotopes together with actinium-225 and lutetium-177. POINT’s lively scientific trials embrace FRONTIER, a part 1 trial for PNT2004, a pan-cancer program concentrating on fibroblast activation protein-α (FAP-α), and SPLASH, the part 3 trial for PNT2002 for individuals with metastatic castration resistant prostate most cancers (mCRPC) after second-line hormonal remedy.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN CANADA.

Location of Work

This place shall be situated onsite downtown at UHN close to College Avenue and School Road.

Overview

Reporting into the Supervisor of High quality Assurance the High quality Assurance Specialist shall be accountable for:

Creation of ordinary working procedures and different high quality documentation.

Supporting the group with continued compliance and monitoring conformance to established inner procedures and regulatory requirements.

Batch document assessment and remaining batch launch.

Offering steerage and assist to plant personnel to make sure coaching and documentation practices are executed in accordance with cGMP, ICH Pointers, Heath Canada and FDA Code of Federal Rules for aseptic drug merchandise.

Managing high quality occasions and the related investigations on the web site.

Aims and Accountabilities

Take part within the profitable implementation of a high quality system which helps the location’s improvement, scientific and business manufacturing targets. This can embrace doc administration, investigations, audits and the corrective motion/preventive motion program.

Develop processes and procedures for the standard division, below the steerage of the QA Supervisor.

Writer investigations and procedures.

Assign acceptable reviewers and approvers for procedures, insurance policies and coaching.

Assessment batch information, product specs, Certificates of Evaluation and all different supporting documentation associated to the discharge of product.

Help and take part with inner/exterior audits.

Take part in deviation investigations, CAPA, Change Controls, SOPs, and so on. as relevant.

Problem paperwork and logbooks as required.

Could carry out different associated extra duties as assigned.

Necessities

B.Sc within the life sciences diploma; together with pharmacy, chemistry or different equal qualification if most well-liked.

4-6 years of expertise in a GMP or equal regulated surroundings

Expertise in vendor qualification and audit.

Coaching and expertise in documentation management, change management, CAPAs and assessment of high quality information.

Understanding of Well being Canada, FDA and EU GMP rules, with particular information of the rules as they pertain to sterile merchandise most well-liked.

Means to work independently and possess wonderful organizational abilities.

Expertise with digital knowledge programs is a plus.

Competencies

Wonderful oral and written communication abilities

Demonstrated means to operate properly in a collaborative staff surroundings

Means to plan, develop and execute a number of tasks below tight timelines

Function and execute with an excessive sense of urgency

Wonderful organizational and interpersonal abilities

Demonstrated proficiency in technical writing

Means to handle a number of tasks, set priorities, and work in a fast-paced surroundings

Advantages

Eligible for annual incentive bonus plan and inventory choices

Healthcare plan (medical, dental, imaginative and prescient) – efficient day 1

Incapacity

Life insurance coverage

RRSP matching plan

Paid Time Off (Trip, Private Days, Sick Days & Public Holidays)

$500 health reimbursement

$50 cellphone reimbursement per pay test ($1,300 per 12 months)

This position works in a hospital setting and it’s obligatory for all workers to finish well being screens earlier than onboarding. Within the occasion the display outcomes present non-immunity, vaccines could should be administered.

All candidates who’re provided employment with POINT Biopharma shall be topic to a background investigation. Provides of employment are contingent on the profitable completion of a background investigation performed in accordance with POINT Biopharma coverage and state legislation.

POINT Biopharma doesn’t discriminate on the idea of age, race, colour, faith, gender, sexual orientation, gender id, gender expression, nationwide origin, protected veteran standing, incapacity or every other legally protected standing.

We don’t settle for unsolicited inquiries or resumes from companies.