QC Manager

Pharmagend Global Medical Services Pte Ltd; Singapore; On-site; SGD 120,000 - 190,000; Full time

Job summary

Pharmagend Global Medical Services Pte Ltd is seeking an experienced Laboratory QC Manager to lead quality control operations in a GMP-regulated setting in Singapore. You will oversee lab activities, instrument qualification, documentation, training, and compliance with FDA/USP/ICH guidelines within a fast-paced pharmaceutical environment.

Responsibilities include managing raw material and packaging material testing, ensuring data integrity, leading investigations, and driving continuous

Qualifications

• Bachelor's degree in Chemistry, Pharmaceutical Science or related field.
• Minimum 8 years in pharmaceutical QC, analytical testing, GMP laboratory operations.
• Minimum 3 years in supervisory/managerial role in GMP setting.
• Experience with raw material and packaging material testing preferred.
• Experience in method verification, method transfer, investigations, audit support, and instrument qualification preferred.

Responsibilities

• Lead QC activities: lab purchasing, inventory checks, raw material sampling.
• Lead NPI for raw materials and packaging materials; draft specs, SOPs, and validation documents as needed.
• Release RM/PM per SCM/production plan and ensure SOP compliance.
• Oversee instrument management: qualification/calibration planning, vendor coordination, and lifecycle management.
• Maintain data integrity, traceability, and real-time documentation within QC activities.
• Foster EHS in the lab and support audits; lead training and personnel development in QC.
• Manage QC team performance, KPIs, and staff development; participate in hiring decisions.
• Escalate quality events and trends to QC Head; ensure disposition of samples; initiate CAPEX for equipment.

Skills

Quality Control

GMP

Team leadership

Laboratory management

Regulatory compliance

Method verification

Instrument calibration

Education

Bachelor's degree in Chemistry or related

Tools

QMS software

LIMS

Job description

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.