QC Team Lead

Basic qualifications:

Basic Education

Educated to a minimum of primary or higher science based degree level.

Basic Experience

3-4 years experience in a pharmaceutical / healthcare industry in an analyst/ senior analyst / supervisory capacity.

Preferred qualifications:

Preferred Education

Third level chemistry based degree or associated science (preferably post graduate).

Preferred Experience

  • Understanding of appropriate directives, standards, policies and guidelines and ability to implement appropriately, e.g.:

ocGMP (CFR 210/211)

oMDD (93/42/ EEC)

oISO 13485 2012

oQMS GSK Policies and Procedures

oEU GMP

oPharmaceutical Affairs Law Japan

oMHLW Ordinance No 169

oMHLW Ordinance No 179

oMHLW Ordinance No 2

oCFR 820

oGSK Facility & Technical Process Guides

  • Understanding of the quality systems for Medical Device and Medicinal Products and an understanding of the relevant regulatory requirements for markets.
  • Knowledge of products and the manufacturing processes for Medical Device and Medicinal products.

Details:

Job Purpose

To lead and supervise all activities associated with their quality control stream and ensure all such relevant activities comply with all GMP, GLP, EHS and regulatory requirements.

Job Responsibilities:

Quality Responsibilities

  • Ensure QC team work in a compliant manner and in accordance with Good Manufacturing and Good Laboratory Practices.
  • Perform duties in a compliant manner and behave in accordance with site SOP's, Quality Management System standards and guidelines and relevant legal requirements.
  • Ensure Adherence to all quality standards – "Lead by Example".
  • Read and understand relevant Standard Operating Procedures, Global Quality Procedures and Management Policies relevant to your job role.
  • Ensure existing quality risk actions are completed to schedule and that any new risks are identified and escalated to the QC manager immediately.
  • Ensure all quality metrics are adhered to.
  • Ensure all quality audit findings are thoroughly investigated and effective corrective and preventive action plans are put in place to prevent a re-occurrence. Ensure timelines are adhered to.
  • Be aware of the impact of your job activities on quality.
  • Training of QC team in accordance with GLP.
  • Review of completed analytical reports prior to OQ approval.
  • Preparation, review and approval of in-house procedures e.g. SOPs, monographs, protocols etc.
  • Decision-making and liaison with internal departments to disposition product in accordance with GMP.
  • Troubleshooting analytical problems.
  • Participate fully in our site's quality initiatives and support quality continuous improvement programmes.
  • Communicate with the QC Manager on a regular basis on QC status
  • Escalate issues to the QC Manager, OQ Manager and Quality Director as appropriate.
  • Ensure Halal requirements are met in accordance with General Guidelines of Halal Assurance System LPPOM MUI for applicable Medical device Products/Markets.

Environmental Health & Safety (EHS) Responsibilities

  • Ensure QC team work in a safe manner and in accordance with Good Laboratory Practices.
  • Perform duties in a compliant manner and behave in accordance with site SOP's, GSK EHS standards and guidelines and relevant legal requirements.
  • Ensure Adherence to all safety standards – "Lead by Example".
  • Read and understand Standard Operation Procedures applicable to role.
  • Report all accidents, incidents and any EHS issues using the appropriate process /system to your manager or, if required, the Occupational Health Advisor.
  • Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping standards.
  • Be aware of the impact of your job activities on EHS.
  • Conduct formal / informal safety audits / checks including safety contacts on a daily / weekly basis and ensure appropriate actions are identified to avoid reoccurrence and all identified actions are closed in a timely manner.
  • Report any damaged or unsafe equipment or practice.
  • Participate in Health & Safety improvement programmes.
  • Ensure that there is adherence to the garbing procedure and proper use & maintenance of PPE.
  • Ensure all Risk Assessments are completed to schedule and that any new risks are identified and escalated to your manager immediately
  • Ensure EHS audit findings are thoroughly investigated and effective corrective and preventive action plans are in place to prevent a re-occurrence. Ensure timelines are adhered to.
  • Generate Accident Reports & participate in Accident / Incident investigation where required.
  • Chair weekly EHS meeting as per schedule and support monthly meetings as required.
  • Ensure safety culture is embedded within the QC area.
  • Ensure near miss target is achieved as per site scorecard.
  • Escalate issues to the QC Manager as appropriate
  • Manage the area during any unforeseen situations:

Fire Alarms

Accidents / Incidents.

Chemical Spillage's etc

People Management Responsibilities

  • Provide motivational and effective leadership for team members.
  • Ensure efficient operation of the QC team and that the highest quality and safety standards are maintained at all times within QC.
  • Manage training and development plans for direct reports. Monitor personnel performance, time keeping and attendance and provide regular updates to the QC Manager.
  • Responsible for direct supervision of the following activities :

Sampling and testing activities relating to raw materials, packaging components, bulk product, finished product, stability and validation ensuring lead-times are adhered to

Ensure there is a balanced workload among analysts

Manage holiday applications and holiday cover

  • Ensure thorough understanding of HR legislation and policies.
  • Ability to provide key input into site management decisions.
  • Building capability in Team
  • Drive accountability within the team
  • Must have can do attitude.

Contact information:

You may apply for this position online by selecting the Apply now button.

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