Overall Objectives of the Position
- This role is responsible for managing quality control lab to achieve excellence in analytical areas through competent and capable staff and suitable equipment, technologies and procedures and to support NMCC products lifecycle approach.
- Provide support for laboratory running such as management of reagents, reference standards, Instrument Routine Maintenance, HSE, documentation (SOP / Work Instruction / testing monograph / primary record, etc) and other activities in lab.
- Lead/Supervise laboratory tests for in-coming material, in-process control, finished product (e.g. Wet Chemistry Test and Microbiological Test, Instrumental Test like ICP, AAS, IC, Voltammetry, water system tests (PW, WFI, PS), environment monitoring, elemental impurity study, stability study) through operating standard and specialized laboratory equipment in accordance with SOPs, working instructions procedures and testing monographs, and document properly in a timely manner.
- Be able to identify the critical points for QC lab management.
- Manage lab equipment qualification/calibration, method transfer and validation.
- Problem solving for analytical equipment and processes.
- Contribute to problem solving associated with laboratory work such as OOE/OOS investigation.
- Maintain high level of safety, environmental protection and housekeeping in all laboratory operations, comply to relevant Quality System cGMP requirement. Contribute also in the system establishment.
- Make sure the whole PIS QC department comply with company EHS safety regulations and master skill of safety work and emergency rescue knowledge
- Take responsibilities in assigned projects as appropriate.
- Be a valuable team member of Quality organization and develop self and others (e.g. lab staff/new comer training) through close teamwork and cross functional/sectional activities. Be a continuous improver.
Education and Qualification Required
Education
- Bachelor or above. University level Attainment of qualified/responsible person status under local/international legislative requirements. Local language, good English speaking, reading and understanding.
- Pharmacy, Pharmaceutical Analysis, Chemistry or related major field.
- Above 10 years’ experience in Pharma industry with +5 years’ management role.
- Good knowledge of GMP
- Familiar with related local regulations
- Leadership skill
- Willing to learn and open to new idea, constructive thinking, initiative
- Coaching ability
- Time management skill
- Work under pressure
Functional area: Quality
US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
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