Quality Control Laboratory Manager

Responsibilities

Laboratory Operations and Quality Management System:

• Lead and responsible for QC activities such as lab purchase, inventory check.
• Lead and participate in the New Product Introduction for raw material and packaging material.
• Draft SPEC/STP/AWS with the information provided by TT for raw material and packaging material.
• Draft method validation protocol and report if needed.
• Conduct MV/MT as needed.
• Release RM/PM according to the SCM plan or production plan.
• Write and/or review controlled documentation related to laboratory operations or testing such as SOP's.
• Ensure implementation of SOP for all corresponding activities.
• Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.
• Lead and participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.
• Initiate change control documents.
• Escalate the quality events and trends as appropriate to QC Head.
• Responsible for disposition of samples upon confirmation.
• Initiate CAPEX for equipment purchases.
• Support in budget preparation for QC Laboratory.
• Any other activities as and when assigned by the Superior.

Instrument Management:

• Maintain QC instrument list, and keep updated.
• Responsible for instrument qualification/calibration planning.
• Contact third party vendor to perform qualification/calibration.
• Track the third party service, confirm the service quality, update to QA/finance if needed.
• Whole life cycle management for new instrument, prepare URS/DQ/IOQ/PQ.
• Make sure all the qualification/calibration are performed according to the plan.
• Update and track repair if needed.

Training/Documentation Compliance:

• Write and/or review controlled documentation related to laboratory operations or testing such as SOP's, analytical protocols, analysis reports, forms and validation documents.
• Maintain data integrity in Quality Control activities and ensure appropriate traceability.
• Ensure real time documentation, maintain data integrity and appropriate traceability.
• Maintain the training record for the whole QC team.
• Schedule and track the training for both new team members and current team members.

Audit Management:

• Ensure compliance with FDA regulations and internal controlled procedures in the Quality Control Laboratory.
• Ensure readiness of QC Laboratory in internal/external laboratory audits.
• Remain abreast of current regulatory, pharmacopeia and cGMP trends.
• Serve as subject matter expert on laboratory instrumentation and compliance issues.

People Management including technical training & development / Resource Management:

• Participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance, and performance of laboratory personnel.
• Support the QC Department training program by imparting training to new staff and complying with Analyst Qualification procedure.
• Lead the QC team, evaluate competencies, assign responsibilities, monitor performance, counsel and provide guidance. Plan & monitor the training and development requirements, motivate staff appropriately to build a committed, motivated & competent team.
• Participate in personnel decisions (interviewing, hiring, performance appraisals, promotions, termination, staff development, improvement plans) regarding subordinate staff.

EHS:

• Maintains a safe laboratory environment by complying with recommendations made by EHS.
• Encourage team members to follow safe laboratory practices and report EHS concerns promptly.

Qualification Requirements:

Education:

Bachelor's degree or above in Chemistry, Pharmaceutical Science, Analytical Chemistry, Material Science, or a related discipline.

Experience:

• Minimum 8 years of experience in pharmaceutical QC, analytical testing, raw material testing, packaging material testing, or GMP laboratory operations.
• Minimum 3 years of supervisory or managerial experience in a GMP-regulated environment.
• Experience in raw material and packaging material testing is preferred.
• Experience in method verification, method transfer, laboratory investigations, audit support, and instrument qualification is preferred.