QC manager

by Sidsel Xue in Pharmaceutical    8th Apr, 2020       Hong Kong

QC manager

Introduction:

Our client, A Hong Kong pharmaceutical company, need a QC manager based in Hongkong

Responsibilities:

QC Manager Job

-Supervise and direct the overall performance and effectiveness of QC Laboratory to ensure QC activities fulfill PIC/S and FDA GMP requirements.

-Prepare and implement QC department annual plan

-Direct, guide and manage QC team to enhance their sensitivity and profession on quality issue

-Plan and execute QC quality activity plan annually

-Responsible for enhancing data integrity compliance of QC department

-Responsible for daily QC laboratory operations and to ensure all operations are in full compliance with applicable SOPs, GMP requirements and safety guidelines.

-Provide effective leadership including setting individual and department objectives, employee evaluations, leading departmental meetings, providing performance feedback, recognizing employee contributions, coaching and developing staff.

-To support and supervise QC responsibilities for the performance of all in-process, finished product, process validation, method validation and stability testing.

-Provide guidance and risk assessment for the resolution of discrepancies, OOS, unexpected results, lab investigations and Corrective and Preventative Actions.

-Oversee all aspects relating to the QC instrumentation program including; purchase, installation, qualification, PM scheduling and trouble shooting.

-In charge of continuous improvement to the lab in regards to instrument and method life cycle management.

-Interact with internal and external colleagues, regulatory agencies and internal auditors.

-Represent QC at operational and cross-functional meetings; prepares and presents information, provides decision making support at meetings and disseminates information back to QC.

-Responsible for evaluating new technologies and requirements and implementing them as needed to stay current with best practices and new regulatory demands.

-Responsible to manage department staff and HR related issues.

Requirements:

REQUIREMENTS:

BS / Master in chemistry, biology, microbiology and/ or life sciences

Minimum 5 years pharmaceutical experience/laboratory management and/or related pharmaceutical experience.

Previous management level experience.

Thorough knowledge of cGMPs and pharmaceutical manufacturing requirements. Demonstrated auditing and corrective action proficiency.

Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues.

Demonstrated proficiency of root cause analysis as applied in a pharmaceutical manufacturing environment.

Excellent problem solving and decision making skills.

Ability to manage and drive change

Supervisory skills

Computer skills

Knowledge of document management/quality systems

Strong communication and interpersonal skills

Building relationships with other departments

Interviewing and presentation skills

Statistical Analysis capability

Job suggestion for you

Sidsel Xue

Sidsel Xue

For more information about this job opportunity please contact our consultant.

Latest jobs


HRBP

by Claire Feng in Packaging
8th Apr, 2020 RMB 20k - RMB 25k

Senior sourcing(Category leader)

by Claire Zheng in Retail
8th Apr, 2020 RMB 17k - RMB 28k

Junior Sourcing

by Claire Zheng in Retail
8th Apr, 2020 RMB 10k - RMB 19k

Costing Manager财务成本经理

by Yolanda Ye in Packaging
8th Apr, 2020 RMB 17k - RMB 26k

Gemini Personnel

Gemini Personnel

Social Links