Quality Control Analyst

Quality Control Analyst - Stabilities (8459)

**Career Opportunities: Quality Control Analyst - Stabilities (8459)**

Requisition ID **8459** - Posted - **Canada** - **Quality** - **CA - Laval** - City (1)

Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.

Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices and hospitals across the country.

At Bausch Health, we invest in our employees and we believe in the importance of cultivating performance and outdoing ourselves in finding new and better solutions with the aim of responding innovatively and effectively to current needs.

**1. Purpose of the position**
- Ensures the management of the stability program for the annual selection of batches, for the selection of batches related to the projects of the validation department as well as for the various stability change controls according to the procedures and protocols.
- Ensures the creation and revision of documents related to the department as well as the final approval of the results
- Ensures the conformity of the documents generated
- Follows up with internal and external partners.
- Assists the stability supervisor in tasks related to the stability department

**2. Main functions**

COORDINATION OF LOT SELECTION
- Performs the annual plan of the batches for which a stability study is required according to the annual program, the validation batches or according to the various change controls.
- Ensures the selection of lots on a weekly basis as well as the receipt of these
- Ensures follow-up with internal partners to properly select the lots
- Participates in various meetings.

DOCUMENTATION
- Ensures the creation and revision of stability protocols in accordance with the regulatory files of the various products.
- Follows up on change controls that require changes in documentation
- Participates in the creation and review of stability procedures

SAMPLES AND STABILITY RESULTS
- Performs the verification of labels on the samples as well as the verification and approval of the stability studies of the results in different LIMS stability systems according to the protocols and procedures in force
- Performs the review and final approval of stability files
- Ensures that the results obtained are in line with the product trend and reports any anomalies
- Sends stability samples that require analysis in an external laboratory
- Ensures that stability results required for AR and APR are available on time
- Follow up with internal and external partners to respond to various requests

ASSISTS THE STABILITY SUPERVISOR
- Delegate of the stability supervisor
- Assists the stability supervisor in investigations, deviations and incidents related to the stability department
- Assists the stability supervisor in all other tasks related to stability.

**3. Resources**

No budget to manage. The expenses to be incurred are the responsibility of the department head.

**4. Knowledge and skills required**:
a) Required training

Technical / Bachelor's degree in Chemistry or related sciences or equivalent combination of experience and academic training.

b) Languages

French and English

c) Specific technical skills

Ability to work in both official languages.

GMP regulations (Health Canada, FDA, European Standards)

Document Management

Knowledge of SQL - LIMS stability an asset

d) Knowledge and skills

Attention to detail and rigor in the management of files and data

Sense of organization, autonomy, priority management

Team spirit

Ability to manage multiple files simultaneously

Flexibility

Ability to manage ambiguity
- The masculine is used in this publication without prejudice for the sake of conciseness._
- Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates._

Bausch Health is an EEO/AA employer M/F/D/V.