Quality Control Analyst Ii

7 days ago

Aurora, Canada Piramal Healthcare Full time

At **Piramal Healthcare**, we make life changing, lifesaving medications. We believe that by bringing the best-in-class talent on board—and providing cutting-edge growth and learning opportunities—we are creating a positive impact on patients, customers, and the communities we serve. Thus, we offer our employees an abundance of learning opportunities for their full potential to build upon.

The Quality Control Analyst II is expected to work **continental shifts**: 7am to 7pm/7pm to 7am, 3 shifts one week 4 shifts the next with every other weekend off and rotate days-to-nights every two weeks.

**JOB PURPOSE**:
Perform lab testing to standards of quality and efficiency in support of our customers and our production facilities

**JOB RESPONSIBILITIES**:

- Independently execute and troubleshoot all shift activities related to manufacturing as prioritised by the QC Manager or designate (on-shift senior member)
- Effectively cross-trained and competent in all lab instrumentation and all lab procedures and activities (ie. raw material method development, IPC, product, raw material testing and as required all testing/calibration activities in support of Analytical Services activities)
- Conduct required testing and lab activities (including third party and stability activities as requested) under current Good Manufacturing practices (cGMP) in support of new projects and manufacturing (including data interpretation, documentation and reporting of results, calibrations and PMs) under mínimal supervision
- Execute lab investigations and deviations under the guidance of QC Manager or senior member (eg. out-of-specification reports)
- Assist in training staff in instrumentation and procedures according to internal SOPs
- Work as an effective team member to meet departmental goals, sharing knowledge with team members
- Provides technical troubleshooting support or training to other team members where appropriate (e.g. procedural, instrument or method issues).
- Peer review of colleagues analytical work and communication to production facilities
- Maintain active continuous cross-training in support of other departmental objectives (eg. third party, stability activities, lab initiatives)
- Ensure compliance to cGMP and Good Laboratory Practices (GLP) according to Piramal’s SOPs.
- Participate in opportunities to develop and disseminate current knowledge of analytical chemistry and technology
- Promote and ensure safe and clean lab operations
- Perform departmental tasks such as cleaning, supply ordering, instrumentation/technology training, etc;
**EDUCATIONAL AND PROFESSIONAL ATTAINMENT**:

- B.Sc. in Chemistry or related field from a recognized educational institution

OR
- Community College diploma in a related field and a minimum 2-3 years of relevant experience in analysis of pharmaceutical products

**JOB RELATED WORK EXPERIENCE REQUIRED**:

- 2-3 years’ experience in analytical chemistry within a pharmaceutical company.
- Good understanding of all lab activities related to manufacturing

**SKILLS AND KNOWLEDGE**:

- Understanding and operational knowledge of FDA, ICH and USP regulations
- Strong analytical chemistry instrumentation skills (e.g. HPLC, GC) and some experience in cleaning method validations (calibration and method development an asset)
- Strong experience operating in a cGMP environment
- Good organizational, multitasking and communication skills

**COMPETENCIES**:

- E.H.S Focus
- Effective Communication
- Results Orientation and Flexibility
- Technical Knowledge
- Team Orientation

**Piramal Pharma Solutions **is an equal opportunity employer. We prohibit discrimination based on age, color, disability, national origin, race, religion, sex, sexual orientation, and any other legally protected class in accordance with applicable federal, provincial and local laws. We are also committed to creating and maintaining an inclusive and accessible workplace. If you are contacted to be part of our recruitment process and require accommodation during it, please let us know.

**Job Types**: Full-time, Permanent

Ability to commute/relocate:

- Aurora, ON L4G 4C3: reliably commute or plan to relocate before starting work (required)

Work Location: In person

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