Manufacturing Investigator

2 days ago

Steinbach, Canada Bausch Health Companies Full time

Manufacturing Investigator (Pharmaceutical) (9103)

**Career Opportunities: Manufacturing Investigator (Pharmaceutical) (9103)**

Requisition ID **9103** - Posted - **Canada - Steinbach** - **Manufacturing / Operations** - **CA - Steinbach** - 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.

**Role Title**:Manufacturing Investigator**

**Department**:Production**

**Reports to**:Senior Manager, Manufacturing**

Reporting to the Senior Manager, Manufacturing, the incumbent will be combining an understanding of cGMP, root cause analysis, processes/facility equipment and technical writing skills, the Manufacturing Investigator is responsible for investigating and identifying root cause of non-conformances, writing and managing investigations, immediate corrective actions and long term CAPAs. The Investigator must possess skills to coordinate cross-functional interactions and is critical in ensuring investigations are well-written, thoroughly investigated and closed within defined timeline.

Assist the site Qualified Person in Charge (QPIC) in maintaining the Controlled Substance program as an Alternate Qualified Person in Charge (AQPIC) and ensuring adherence to the provisions of the Controlled Drugs and Substances Act and compliance with all regulations and site procedures

**Responsibilities**:

- Ensure that all activities related to the investigation and resolution of non-conformances are performed in a timely manner and in compliance with company and regulatory requirements.
- Leads and writes non-conformances investigation reports.
- Works with stake holders to develop Corrective Actions and Preventative Actions (CAPA).
- Spends time on Manufacturing floor learning and understanding processes and getting to know team members.
- Collaborates with multiple cross-functional teams.
- Manage investigations using DMAIC tools and other investigative tools.
- Responsible for accurately compiling data for tests, products, trending for statistical reports, to support the investigation.
- Ensure documentation is expedited in a timely manner to facilitate the release of product to market.
- Participate in occupational health, safety, and wellness.

**Alternate Qualified Person in Charge (AQPIC)**
- Adhere to the provisions of the Controlled Drugs and Substances Act and ensure compliance with all regulations and site procedures
- Fulfill duties as AQPIC as governed by internal SOPs and controlled substances regulations.
- Preparing, approving, and maintaining Standard Operating Procedures (SOPs).
- Provide training to employees.
- Assists with the monthly physical inventory count and reporting of controlled substances.
- Maintaining and reviewing records for audits.
- Participates in receiving and shipping controlled substances
- Participate in Regulatory inspections and prepare audit responses in a timely manner for Management review.

**Education and Experience**:

- Bachelor of Science in Chemistry, Chemical Engineering, Pharmacy, Pharmacology, or other directly related field
- Minimum of three years’ experience in a manufacturing environment within a heavily regulated industry such as pharmaceuticals, food processing, or medical devices which follows cGMP
- A combination of Education and Experience may be considered
- Experience working in a Lean environment is preferred

**Required competencies/Abilities**:

- Excellent planning and organizational skills
- Ability to adapt quickly to changes and to redirect priorities in a fast-paced environment
- Strong analytical, critical thinking and problem-solving skills
- Strong interpersonal skills with the ability to interact effectively with individuals across the organization
- Excellent verbal and written communication skills
- Continuous improvement mindset
- Excellent knowledge of Microsoft Office and ERP systems (SAP is an asset)

**Why Bausch Health?**

Bausch Health is a dynamic, growing company with a dedicated team committed to excellence and to helping Canadians by providing them with important, high-quality healthcare solutions. It is a progressive, exciting place to work where opportunities abound for current and new employees to help make a difference for Canadians.

We strongly believe the success of Bausch Health coincides with the achievement of personal and professional goals. We are a progressive, exciting place to work - where opportunities abound for new

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