Quality Systems Specialist

4 weeks ago

Steinbach, Canada Bausch + Lomb Full time

**Bausch + Lomb Corporation, (NYSE/TSX**: BLCO), is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.

The company is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses, and other eye surgery products.

Our highest priority is the well-being of the people we serve. By listening to our customers and patients, by constantly honing our innovation edge, by executing with integrity and excellence, we strive to earn the trust of our partners and stakeholders.

Over the last 167 years, Bausch + Lomb has become a global hallmark for innovation and quality. Our talented and motivated colleagues work relentlessly to invent new materials, engineer new technologies, and ultimately bring new innovations to help people see better to live better.

**Purpose of the position**:

- Management of Third-Party Suppliers system documentation update and review
- Ensure compliance status of each batch prior disposition activity
- Provides solid expertise for the submission and update of our drug establishment license, medical devices and natural health products license with Health Canada
- Perform external audits
- Support Quality Systems, such as internal audit, change control, training, complaints
- Prepare periodic Quality System trending studies to management
- Support product release team and perform release product to market

**2. Main functions**:

- Responsible to perform batch dispositions to Canada market
- Responsible for managing the third-party supplier system to ensure that documentation required by regulations is available and reviewed
- Ensure compliance status and support all quality activities and initiatives related to DC
- Update Drug Establishment License to support changes to the DEL, site license and the Medical Device License, for annual updates as well as addition of foreign sites to the DEL
- Conduct external inspections and necessary audits of 3PS and vendors to ensure they are operating in compliance with cGMP and Valeant quality level of expectations. Issue vendor inspection reports, including any necessary recommendations to ensure the follow-up of actions’ implementation, when required
- Support other quality systems such as change control, complaint, training, quality agreements, annual product reviews, master batch records, etc.
- Ensure that appropriate Technical and Quality Agreements with all suppliers are in place
- Establish meaningful key performance indicators for the site’s Quality Systems
- Regularly launch revisions of SOPs and ensure proper follow-up in order for documents to be effective and implemented in a timely manner
- Regularly provide status and trending studies of quality-related indicators to Management

**3. Other functions**:

- Other responsibilities, as deemed necessary by Manager, Commercial Quality Assurance may be additionally assigned

4. Main business relations
- Reports to Manager, CMO/Supplier Quality
- Ensures that deadlines are respected and informs suppliers

**5. Knowledge and skills**:
a) Education and training required
- Education: B.Sc. in an appropriate scientific discipline
- Specialized Training: Comprehensive knowledge of cGMP, Health Canada and FDA. Experience in auditing procedures, processes and mechanisms in a GMP environment is highly considered as a plus. Good Understanding of USP and Regulatory expectation regarding Analytical Method Validation criteria (HPLC, GC, etc.)

b) Languages
- Excellent oral and written communication skills in French and English

The masculine is used in this publication without prejudice for the sake of conciseness.

Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.

We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. Accommodations for job applicants with disabilities are available on request.

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