About the role:
Reporting to QC Manager, the QC Project Leader will lead the method transfer of the New product launch products and method validation at Bimeda. The project leader 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, SOP’s 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 Project Leader 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 project Leader will work directly with new product development or external resources to troubleshoot all analytical challenges associated with QC projects.
What you'll do:
- 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.
- 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 processes analytical data for method transfer. Writes technical documents such as methods, specifications, SOPs, method verification or validation protocols and reports, and method transfer protocols 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.
What you bring to the role:
- 5-7 years in a Pharmaceutical Analytical testing lab & supporting stability programs
- B.Sc. in Chemistry, Biochemistry or related discipline
- Analytical Wet Chemistry Lab expertise using the following methods/equipment: titration, pH, Potency, Conductivity, Viscosity, TOC, UV, IR, GC, HPLC/UPLC
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.
PROCESS IMPROVEMENT – involves the business practice of identifying, analyzing, and improving existing processes to optimize performance.
INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.
THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
CHANGE AGILITY/ADAPTABILITY – The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness; initiating, sponsoring, and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose, and embraces change. Strives for continuous improvement.
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.
What We Offer:
- Competitive Salary
- Paid Holidays
- Competitive Vacation Policy
- Paid Sick Days
- Medical, Dental, Vision Insurance
- Pension plan
- Employee Assistance Program
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.