Quality & Compliance Specialist, Analytical Services

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.

**JOB PURPOSE**:
Provide assurance that all data generated from the analytical laboratories AS are accurate, complete and in compliance with data integrity, current Good Manufacturing Practices (CGMP), clients and regulatory agency requirements. Maintains quality and compliance by identifying quality requirements, disseminating standards, policies, and procedures and recommending improvement plans.

**JOB RESPONSIBILITIES**:

- Review all analytical data generated by the Analytical Services laboratory including but not limited to products, method validations, method transfers, stability studies, standard qualifications, R&D samples (as applicable) and any third party samples for accuracy, completeness and compliance to data integrity, written procedures and CGMP regulations
- Review all planned and unplanned deviations for accuracy, completeness and compliance to data integrity, written procedures and CGMP regulations
- Provide analyst and client correspondence on data corrections and reports LIMS release of all tests and samples listed above
- Preparation of stability, standard, validation protocols and other technical documents
- Provide analyst feedback for completion of various reports
- Ensure compliance with internal approved procedures, specifications and protocols of all generated data
- Ensure timely completion of all data review
- Filing of request forms, runlogs, lab numbers and other lab documentation, as required
- Review out-of-specifications, analytical deviations, investigations and run log summaries
- Create and revise Certificates of Analysis and other technical documents as required
- Revise via change control documentation as required
- Participate in the implementation of continuous improvement initiatives as they relate to quality activities (e.g., introduction of new technology and automation with respect to data acquisition, electronic review, quality management systems, LIMS, tracking project spreadsheets, etc.)
- Participate in internal and external audits
- Provide data and information pertaining to lab or systems for internal or external clients as requested
- Perform other related assignments and projects as required

**EDUCATIONAL AND PROFESSIONAL ATTAINMENT**:

- B.Sc. degree in Chemistry or related science

**JOB RELATED WORK EXPERIENCE REQUIRED**:

- 2 years related experience and within the pharmaceutical industry preferred.
- Commensurate with education (approx. 2 or more yrs. with B.Sc.; approx. 5 or more yrs. with post-secondary school education)
- Knowledge of relevant regulations and guidance required to ensure site compliance
- Knowledge of relevant regulations and guidance required to ensure site compliance

**SKILLS AND KNOWLEDGE**:

- Good knowledge of CGMP requirements, ICH, FDA guidelines
- Knowledge of analytical instrumentation and techniques
- Skills in interpreting and trending analytical data and instrumentation/equipment software (Empower and stand alone instruments)
- Understanding of method development, validation, transfer and stability requirements
- Strong communication skills, both written and verbal
- Extensive knowledge of compliance in the pharmaceutical manufacturing processes (API)

**CRITICAL ATTRIBUTES**:

- EHS Focus
- Passionately Reliable
- Rapid Responsiveness
- Innovative Efficiency
- Teamwork
- Detail 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