No deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
This role ensures that all raw materials meet established quality standards and regulatory requirements to support manufacturing processes. The ideal candidate will have strong attention to detail, experience in analytical testing, and knowledge of pharmaceutical QC practices.
Key Responsibilities:
- Conduct Testing and Analysis: Perform qualitative and quantitative testing on raw materials following standard operating procedures (SOPs), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).
- Sample Preparation: Prepare samples of raw materials for analysis using appropriate techniques and equipment, such as HPLC, GC, FTIR, UV-Vis spectroscopy, and wet chemistry methods.
- Documentation and Reporting: Accurately document test results and observations, maintain detailed laboratory records, and prepare reports in compliance with regulatory standards.
- Compliance and Safety: Adhere to all quality and safety standards within the laboratory, ensuring all work is conducted according to regulatory guidelines (FDA, EMA) and company policies.
- Instrument Calibration and Maintenance: Ensure that laboratory equipment is properly calibrated and maintained; troubleshoot issues and coordinate with the maintenance team as needed.
- Inventory Management: Monitor raw material inventory levels, including reagents and supplies, and coordinate with the purchasing team to replenish stocks.
- Continuous Improvement: Participate in continuous improvement initiatives to enhance lab efficiency, accuracy, and safety, and identify potential areas for process optimization.
- Collaboration and Communication: Work closely with cross-functional teams, including production, QA, and R&D, to ensure timely support and resolution of QC issues.
Qualifications:
- Education: Diploma or Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
- Experience: 13 years of experience in a QC laboratory within the pharmaceutical or biotech industry, with a focus on raw materials (experience with GMP and GLP preferred).
- Technical Skills: Proficiency in analytical testing techniques, especially HPLC, GC, FTIR, and wet chemistry methods. Familiarity with Laboratory Information Management Systems (LIMS) is a plus.
- Attention to Detail: Strong attention to detail and accuracy in testing, documentation, and reporting.
- Regulatory Knowledge: Understanding of industry regulations and standards, including FDA, ICH, and USP guidelines for raw materials.
Work Environment:
- Ability to work in a laboratory setting, which may involve exposure to chemicals and use of protective equipment.
- May require occasional lifting of equipment or samples (up to 25 lbs).
