QC Manager - #1164662

Key Responsibilities:

1. Laboratory Operations and Quality Management System:

a. Lead and responsible for QC activities such as lab purchase, inventory check, raw material sampling.

b. 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

c. Release RM/PM according to the SCM plan or production plan

d. Write and / or review controlled documentation related to laboratory operations or testing such as SOP's.

e. Ensure implementation of SOP for all corresponding activities.

f. Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.

g. Lead and participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.

h. Initiate change control documents.

i. Escalate the quality events and trends as appropriate to QC Head.

j. Responsible for disposition of samples upon confirmation.

k. Initiate CAPEX for equipment purchases.

l. Support in budget preparation for QC Laboratory.

m. Any other activities as and when assigned by the Superior.

2. Instrument Management

a. Maintain QC instrument list, and keep updated

b. Responsible for instrument qualification/calibration planning

c. Contact third party vendor to perform qualification/calibration

d. Track the third party service, confirm the service quality, update to QA/finance if needed

e. Whole life cycle management for new instrument, prepare URS/DQ/IOQ/PQ

f. Make sure all the qualification/calibration are performed according to the plan

g. Update and track repair if needed

3. Training/Documentation Compliance:

a. Write and / or review controlled documentation related to laboratory operations or testing such as SOP’s, analytical protocols, analysis reports, forms and validation documents.

b. Maintain data integrity in Quality Control activities and ensure appropriate traceability.

c. Ensure real time documentation, maintain data integrity and appropriate traceability.

d. Maintain the training record for the whole QC team

e. Schedule and track the training for both new team members and current team members

4. Audit Management:

a. Ensure compliance with FDA regulations and internal controlled procedures in the Quality Control Laboratory.

b. Ensure readiness of QC Laboratory in internal / external laboratory audits.

c. Remain abreast of current regulatory, pharmacopeia and cGMP trends.

d. Serve as subject matter expert on laboratory instrumentation and compliance issues.

5. People Management including technical training & development / Resource Management:

a. Participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance, and performance of laboratory personnel.

b. Support the QC Department training program by imparting training to new staff and complying with Analyst Qualification procedure.

c. 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.

d. Participate in personnel decisions (interviewing, hiring, performance appraisals, promotions, termination, staff development, improvement plans) regarding subordinate staff.

6. EHS:

a. Maintains a safe laboratory environment by complying with recommendations made by EHS.

b. 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.