Job Description
Job Summary
In this role, you will bee accountable for day-to-day performance of team/s safety, quality, delivery, cost and productivity. Manage teams of QC Technicians & Team Leads in execution of QC processes, schedule and personnel to ensure smooth operational activities work-flow and work compliance. And promote better quality mindset through inter-department collaborations
Essential Duties and Responsibilities
- Oversee resource management and team schedules for smooth execution of daily operational tasks in QC while meeting daily inspection targets and support Work In Progress (WIP) controls within team(s)
- Support qualifications of inspectors to independently perform responsibilities for competency/ proficiency capabilities in inspections, measurements, sampling, Quality audits and defect recognition.
- Ensure proper product release and rework activities per procedures to support delivery requirements
- Lead product characteristics trend monitoring with effective escalation and follow-ups
- Demonstrate leadership, teamwork, and problem-solving support to resolve escalated operational issues collaboratively and ensure proper batch segregation
- Define goals, clearly communicate these objectives and monitor/correct/recognize work performance respectively. Coach and counsel QC employees.
- Manage and resolve QC employee's relation issues and disputes
- Manage onboarding activities for new QC employees for training and qualification
- Manage ongoing activities for existing QC employees for training and requalification
- Identify future training needs and enhance QC employees career opportunities
- Responsible to review SOI revisions to enhance improvements for better workflow
- Manage Deviation/Out-of-Spec report closures, batch dispositions while ensuring proper root cause analysis and CAPA identification
- Accountable for on time operational updates for Tier meetings of the LDMS system
- Attend Tier meetings as QC representative, and ensure Tier 1 (Shift Start Up) meetings occur within QC
- Promote and support site initiatives including safety programs, lean initiatives, training programs and consistently interpret and apply policies, procedures among employees
- Manage non-routine requests from departments (eg validations, investigations, improvements, projects, product transfers, non-routine testings, non-conformance reports, etc)
- Support Technology Transfer process as required.
- Other duties as assigned by superior.
Additional Responsibilities
- Participate in special project teams as assigned.
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
- Exhibits regular, reliable, punctual and predictable attendance.
Education
- Bachelor's Degree Degree in Technical or Engineering preferred
Work Experience
- Preferably 3 years work experience in QA/QC related activities.
- Added advantage with SAP, cGMP, Basic Lean and/or ISO working experience.
- Preferably with exposure to medical device, pharmaceutical or related manufacturing environment.
Preferred Knowledge, Skills and Abilities
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
- Minimize waste, always ensure efficient work execution by continuous improvements.
- Able to comply with the company’s safety policy at all times.
- Ensure use of Personal Protective Equipment (PPE) in respective work environments for all members within the shift/s
- Report unsafe conditions or acts to responsible persons for corrections and improvements.
- Ensure risk assessment control practices are adopted per HIRA for all members within the shift/s
- Ensure all legal licenses required for the proper usage of QC equipment are effective for all members within the shift/s
- Able to comply with the company’s quality policy at all times.
- Lead monitoring / improvement activities to enhance operational support activities.
- Participate in establishment and maintenance of documented procedure.
- Excellent communication & teamwork skills.
- Self-motivated and positive thinking.
- Ability to remain calm and professional under pressure.
- Proficiency in workplace English for work applications and interfaces.
- Time management skills.
- Able to flex hours to support all shifts as needed.
Travel Requirements
Physical Requirements
Additional Requirements
- Manufacturing environment with rotating working shift patterns
- Overtime and being on-call are required. Occasionally required to work on different shift patterns
- 20/30 Vision minimum, at near and/or far with at least one eye with or without corrective lenses and no color deficiency
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