Assistant Manager / Manager (Raw Material) - QC

Pharmagend Global Medical Services Pte Ltd; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A pharmaceutical company in Singapore is seeking a qualified individual for a QC role. The successful candidate will lead laboratory operations, manage compliance with FDA regulations, and oversee training and documentation. A science degree and at least 4 years of quality control experience in the pharmaceutical industry are required. This is a full-time position with opportunities for professional development.

Qualifications

• Minimum 4 years of quality control experience in pharmaceutical manufacturing industry.
• Experience with laboratory investigation and documentation.
• Proficiency in maintaining data integrity in QC activities.

Responsibilities

• Lead QC activities including lab purchase and inventory checks.
• Draft method validation protocols and ensure compliance.
• Maintain QC instrument qualifications and manage audits.

Skills

Quality control activities

Compliance with FDA/USP/EP/ICH regulations

Document writing and review (SOPs)

Instrument qualification/calibration

Training and development

Education

Degree / Diploma in science related discipline

Job description

1. 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 Tech Transfer 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.

2. 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

3. 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.
• Maintaining the training record for the whole QC team
• Schedule and track the training for both new team members and current team members

4. 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.

5. 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.

6. EHS:

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

Education

Degree / Diploma in science related discipline (e.g. Chemistry, Chemical Engineering, Biomedical Engineering, Biotechnology).

Experience

Degree with minimum 4 years of quality control experience in pharmaceutical manufacturing industry.