Job Summary:
In this role, you will
- Be 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
- 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
- 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 1, Tier 2, Tier 2.5 & Tier 3 of the LDMS system
Attend Tier 2, Tier 2.5 as QC representative, and facilitate Tier 1 (Shift Start Up) 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)
- Other duties as assigned by superior.
Basic Qualifications:
- Academic qualification of bachelor's degree in engineering or relevant fields.
- Computer literate and good grasp of Microsoft Office.
- Preferably 8 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.
- Preferably minimum 5 years work experience managing a QC team.
- Able to work independently with minimum supervision
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.
Travel Requirements:
Physical and Mental 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