Qualifications and Skills - Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related field. Advanced degrees (e.g., Master's or Ph.D.) are preferred.
- Minimum of [X] years of experience in a pharmaceutical QC laboratory, with progressive experience in a supervisory or managerial role.
- Strong knowledge of analytical techniques, instrumentation, and methodologies commonly used in pharmaceutical QC testing (e.g., HPLC, GC, UV-Vis spectroscopy, dissolution testing).
- Thorough understanding of regulatory requirements, quality standards, and compliance principles related to pharmaceutical quality control.
- Excellent leadership, communication, and interpersonal skills, with the ability to motivate and inspire a diverse team.
- Strong problem-solving abilities, decision-making skills, and attention to detail.
- Ability to effectively manage multiple priorities and deadlines in a fast-paced, regulated environment.
Working Conditions:
- The job may require standing or sitting for extended periods in a laboratory or office setting.
- Flexible working hours may be required to accommodate production schedules and testing priorities.
Note
- This job description is intended to convey information essential to understanding the scope of the position and is not exhaustive. Duties and responsibilities may be subject to change based on business needs and organizational requirements.
- We are an equal opportunity employer committed to diversity and inclusion in the workplace. We encourage qualified individuals from all backgrounds to apply.
Job Description
- We are seeking an experienced and dynamic Quality Control (QC) Manager to lead our QC team at our pharmaceutical factory.
- The QC Manager will be responsible for overseeing all aspects of quality control testing and analysis to ensure compliance with regulatory requirements and quality standards.
Key Duties
Quality Control Operations:
- Oversee and coordinate all QC testing and analysis activities, including raw materials, in-process samples, and finished products, to ensure compliance with established specifications and standards.
- Develop, implement, and maintain robust quality control processes, procedures, and systems to ensure the accuracy, reliability, and reproducibility of test results.
Regulatory Compliance:
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory requirements from agencies such as the FDA, EMA, and ICH guidelines.
- Participate in internal and external audits, inspections, and regulatory submissions as needed.
Method Development and Validation:
- Oversee the development and validation of analytical test methods for QC testing in accordance with regulatory requirements and industry standards.
- Evaluate and implement new technologies, instrumentation, and methodologies to enhance the efficiency and effectiveness of QC operations.
Quality Assurance Support:
- Collaborate closely with the Quality Assurance (QA) team to investigate deviations, out-of-specification results, and quality-related issues, and implement corrective and preventive actions (CAPAs) as needed.
- Provide technical expertise and support for investigations, root cause analysis, and risk assessments related to quality control activities.
Training and Development:
- Train, mentor, and develop QC staff to ensure competency and proficiency in analytical techniques, equipment operation, and quality control procedures.
- Foster a culture of continuous improvement, professionalism, and accountability within the QC team.
Documentation and Record Keeping:
- Maintain accurate and complete records of all QC testing activities, including test results, observations, deviations, and corrective actions, in accordance with SOPs and regulatory guidelines.
