Deskripsi Pekerjaan
Are you a seasoned Quality Control professional seeking to lead in a dynamic pharmaceutical environment? Join Biocon, a global biopharmaceutical leader dedicated to affordable healthcare and groundbreaking innovation. We are currently looking for a Quality Control Analytical (Associate Manager / Manager) to oversee our laboratory operations, ensuring the highest standards of compliance, safety, and product efficacy.
In this pivotal role, you will be responsible for ensuring strict adherence to cGMP, EHS, and GDP regulations while managing the end-to-end testing and release of critical materials and products. If you have a passion for quality, a keen eye for detail, and the leadership skills to drive a team forward, we want to hear from you.
Tanggung Jawab
- Oversee the daily operations of the QC Analytical Laboratory, ensuring full compliance with cGMP, GDP, and EHS regulations.
- Lead the testing and final release of raw materials, intermediates, and finished products according to established specifications.
- Manage and mentor a team of analysts, fostering a culture of quality, accuracy, and continuous improvement.
- Review and validate analytical data, ensuring the integrity, accuracy, and traceability of all test results.
- Investigate and manage product deviations, root cause analyses, and the implementation of Corrective and Preventive Actions (CAPA).
- Ensure all documentation is current, complete, and compliant with regulatory standards and internal policies.
- Collaborate effectively with cross-functional teams, including R&D, Production, and Regulatory Affairs, to resolve quality issues.
- Conduct regular internal audits and inspections to maintain laboratory standards.
Kualifikasi
- Bachelor’s or Master’s degree in Chemistry, Pharmacy, Pharmaceutical Sciences, or a related scientific field.
- Minimum of 3-5 years of experience in Quality Control or Analytical Chemistry within the pharmaceutical or life sciences industry.
- Strong working knowledge of cGMP, GDP, and EHS guidelines and regulatory requirements.
- Proven experience in leading a laboratory team or managing a QC function.
- Expertise in analytical instrumentation and techniques, such as HPLC, GC, UV-Vis, or Mass Spectrometry.
- Excellent problem-solving skills, attention to detail, and the ability to work under pressure.
- Strong communication skills and the ability to document complex technical processes clearly.