Job Title : Quality In Process (QIP), Singapore
Industry : Life Sciences
Department : Quality Unit – CSS
Reports To : Quality Control Manager
FLSA Status : Exempt
SUMMARY OF ESSENTIAL FUNCTIONS:
- Possess the abilities to demonstrate good organizational, teamwork and effective problem-solving skills.
- Be independent and flexible to manage dynamic tight schedules to effectively support operational activities.
- Self-motivated and result oriented to ensure task activities execution and deliver the expected results.
- Possess the understanding of GMP requirements and ensure all operational activities executed per expectations.
- Have good interactive and communication skills to interact with personnel from operational to management level.
- Responsible and assist the development, implementation and maintenance of the quality systems to meet and in accordance to quality standards and regulatory requirements.
SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Manage and execute the incoming products inspection activities thru sampling procedure.
- Responsible for the products acceptance release in system.
- Support in-process inspection to ensure secondary packaging activities meet requirements.
- Ensure correct identity of materials and operational activities compliance per packing instructions.
- Manage and execute the label printing inspection activities thru sampling procedure.
- Responsible for the printed labels acceptance release in system.
- Report non-compliance practices or escalate potential concerns to management team for improvements.
- Perform batch documents review of finished products for acceptance per GMP requirements.
- Support new material qualifications where necessary. Conduct the relevant sampling test requirements.
- Collect environmental, water and air samples as required. Liaise with relevant laboratory for test executions and data analysis.
- Involved in SOPs development, revision and updates for compliance to support the quality system.
- Support Process Deviations management and assist to monitor remedial action plan implementations.
- Support validation activities and ensure the process compliance to procedure/standard requirements.
- Support non-routine tasks assigned by management team.
Education: Preferably with Bachelor Degree or Diploma with min 5 years quality related experiences.
Experience: Possess good knowledge in pharmaceutical related field. Familiar with GMP requirements and have experiences in providing quality support to manufacturing or packaging operational activities. Good knowledge with experiences in Regulatory/International Standards (eg: ISO9001, HSA Guidelines, PIC/S Guidelines, etc) is an added advantage.
- Good mathematics skills, statistical software or application skills preferred
- Understanding of pharmaceutical procedures.
- Candidate must have the ability to work effectively under high pressure with multiple deadlines.
- Candidate must be detailed oriented with good interpersonal skills.
- Candidate must have computer skills with MS Office and capable of quickly learning other software including Documentum, TrackWise and ComplianceWire.
- Mathematical and reasoning ability (Justifications & supporting facts)
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to work effectively under extreme pressure to meet deadlines.
- Require to work in cold environment (2-8oC) (with appropriate clothing) for a few hours routinely.
- Require to work at a height of max 4-5m (with appropriate lifting machine) routinely.
- Good command of English for writing and reading of documents and interaction.
- Significant time needed on computer for system transaction and documentation works, etc.
Interested candidates, please forward your updated resume with a recent photo, stating your expected salary and notice required. We regret that only shortlisted candidates will be notified.