ApplyJob Type
Full-timeDescription
Job Summary:
Supervise the work of laboratory personnel engaged in performing routine finished product testing & stability testing, including planning laboratory work, evaluating work performed and handling procedural and technical laboratory problems. Execute according to high standards of quality at the lab through managing and continuously improving the effectiveness of laboratory quality processes and systems.
JOB DUTIES & RESPONSIBILITIES
- Oversee the testing of bulk release, in-process, finished products, and stability testing.
- Manage and supervise QC laboratory personnel with varying levels of experience, assign work schedules, and ensure tasks are performed according to LIMS.
- Review test results for accuracy and proper documentation. Interpret the results, compare them to established specifications and control limits, and make recommendations on the appropriateness of data for release.
- Review specifications and STMs for in-process and finished products.
- Write and review LIR, CCF, and OOS investigations, including identifying root causes and implementing corrective/preventive actions.
- Supervise lab processes, ensuring timely management of investigations and CAPA implementation to maintain sustainable compliance.
- Review SOPs, stability failure notifications, COAs, and compile stability-related data. Ensure timely release of in-process and finished product COAs.
- Monitor and report trends in bulk, finished products, and stability samples to QC/QA Management.
- Review IQ, OQ, and PQ for new instruments, protocols, and reports.
- Coordinate with other departments such as warehouse, QA, maintenance, purchasing, and R&D to meet operational requirements and adhere to cGMP standards.
- Coordinate sample management, including in-process, finished product, and stability samples.
- Attend meetings with senior management to report and discuss quality control issues.
- Train employees to meet quality standards throughout the production process.
- Monitor finished products for compliance with quality standards and remove non-compliant items.
- Monitor Quality Control, Safety, and cGMP practices to ensure compliance with internal and external regulations.
- Perform other related duties as assigned to meet departmental and company objectives
RequirementsOTHER or ADDITIONAL RESPONSIBILITIES
Management Responsibility
Manage group of scientists, associates and Lab assistant .
Reports to
Senior Manager/ Associate Director / Director
Knowledge & Skills
- Ability to maintain integrity and honesty at all times
- Ability to communicate and lead with transparency
- Accountable for performance and results of department
- Ability to assume additional responsibilities on own initiative
Experience & Education
- A minimum of a Bachelor's in Biochemistry or Chemistry with 8-15 years of experience or a Master’s degree in a science-relate field with 5-10 years of experience in the biotech or pharmaceutical industry is required.
- A minimum of 5 years of supervisory or management experience in Quality Control is essential.
Physical Requirements/Working Environment
Regular Laboratory environment with lab coats, safety glasses, 4-6hrs/day of standing while performing chemical test and able to stand for 4-6hrs/day.
Travel
No Travel requirement.
