QC NPI Supervisor

Job Description

Job Description

Salary : $80,000 - $95,000 / Year

Job Title : QC NPI Supervisor

Location : Cambridge, ON (In-Office)

Position Type : Full-time regular

Shift : Day Shift, Monday - Friday

Vacancy Status : This role is currently vacant

AI Disclosure in Hiring : We do not use artificial intelligence to screen, assess, or select applicants

Job Summary

Reporting to QC Manager, the QC NPI Supervisor will lead the method transfer of the new products, launch products and method validation at Bimeda. The NPI Supervisor will be the subject matter expert for method transfer and validation who is responsible for the more complex analysis using various wet chemistry and instrumentation techniques to assure compliance to cGMP, SOPs and Bimeda quality standards. Acts as subject matter expert in regulatory requirements and expectations for managing method transfer (product monographs as well as general chapters). The QC NPI Supervisor is expected to manage all special projects within the QC department, attend all special project meetings, communicate QC requirements and ensure implementation aligned with business expectations. The QC NPI Supervisor will work directly with new product development or external resources to troubleshoot all analytical challenges associated with QC projects.

Role Specific Requirements

• Leads, coordinate, manage and execute NPI transfer projects. Acts as a subject matter expert in method transfer, verification, validation and for complex analysis using various wet chemistry and instrumentation techniques.
• Supervises a small team of Analysts working during weekends; overseeing all assignments, activity, and ensuring compliance & quality standards are consistently met.
• Prepare transfer plans, conduct required testing, analyze data, troubleshooting and work closely with both R&D and QC Analysts and the NPI team to manage the QC product transfer process and facilitate meeting all associated quality requirements and deadlines.
• Leads the validation, verification and transfer of test methods for pharmaceutical raw materials, in process samples and finished products.
• Track the progress of analytical method validation and transfer projects, openly communicate updates, risks and mitigation strategies to stakeholders and management.
• Assess, compare and perform risk assessments for compendial method compliance according to USP, EP, and other regulations.
• Assess analytical methods and perform gap analysis on analytical methods for NPI. Develop plan and timelines for method transfers, required improvements and justification with approval from the quality unit to ensure compliance.
• Author, review or approve analytical method validation and transfer protocol and reports ensuring sound scientific design, compliance with ICH, pharmacopoeial and regulatory guidelines, industry best practices, and Bimeda s internal procedures.
• Expertise with analytical tests utilizing HPLC / UPLC, GC, UV, IR, FTIR, KF and other laboratory instruments and conducts complex analytical testing for NPI and investigate when required.
• Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP / GLP) and Standard Operating Procedures (SOPs).
• Coordinate transfer of information and materials related to analytical method validation and transfer.
• Verifies and processesanalyticaldata formethod transfer. Writes technical documents such asmethods, specifications,SOPs, methodverification or validation protocols and reports,and method transferprotocols and reports.
• Evaluate global documents against site specific procedures and update the site procedure accordingly.
• Reviews analytical data for accuracy, completeness and compliance to cGMPs and established laboratory documentation standards.
• Generates change requests and all required analytical documentation, and routes documents for review and approvals.
• Strong collaboration, communication and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices across site and functions.
• Collaborates with colleagues and external partners to achieve individual and department goals.
• Ensure continuing compliance with new pharmacopoeial monograph publications for applicable raw materials and finished products.
• Other duties as assigned.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and / or priorities and requirements evolve.

Competencies required for the role

EFFECTIVE COMMUNICATION -is the ability to convey information to another effectively and efficiently, to listen help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.

BUILDING RELATIONSHIPS is the process of developing social connections. This is a fundamental business competency that is the basis for reputation, influencing, closing deals and sustaining business relationships.

LEADERSHIP is the ability of an individual to influence or inspire followers or other members of the organization; to enhance others commitment to their work and to a high -performance culture. Provide motivational support, and the ability to develop and communicate goals in support of the business mission. Provides direction with purpose and alignment to Company vision and values.

ANALYTICAL THINKING / PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.

ENGAGEMENT, DRIVE AND EMPOWERMENT - the ability to convey confidence in employees ability to be successful, especially at challenging new tasks; delegating significant responsibility and authority to engage employees; allowing employees freedom to decide how they will accomplish their goals and resolve issues.

Essential :

Compensation & Benefits :

About Bimeda

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a centurys experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the worlds animals.

Bimedas global innovation program sees eight state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

Bimedas nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.

Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

More info atbimedacareers

Equal Opportunity & Accessibility

At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.We are committed to an inclusive and accessible recruitment process. We are an equal-opportunity employer and assess candidates based on skills and experience. Recruitment records are retained in accordance with Ontario law.