Quality Coordinator

2 weeks ago

Manukau, Auckland, New Zealand Marken Full time
MF-QA-005 v03

Title:

Quality Coordinator

Department:

Quality

Site:

New Zealand

Reportable to:

Regional Quality Manager, APAC

Line Management Responsibilities:

N/A

Main Purpose:

  • Responsible for _
- the implem_
- enta_
- tion_
- _
- of the _
- quali_
- ty proces_
- ses, procedures and p_
- olicies required to manage and control _

  • Marken_
- '_
- s sto_
- rage and d_
- istri_
- bution operations _
- in _

  • New Zeala_
- nd._

  • This_
- will ensure _
- compliance_
- _
- with Good Distr_
- ibution Practice (GDP), _

  • Regi_
- onal and _

  • Local reg_
- ulations and _
- requirem_
- en_
- ts._
- _

  • In con_
- ju_
- n_
- ction with the Glob_
- al Quality Assur_
- ance group, _
- the QC_
- will _
- assist with the impl_
- ementation of p_
- olici_
- es and standa_
- rd_
- s across_
- the b_
- usiness and in the management of Q_
- uality Management Sys_
- tem (QMS) in accord_
- ance with GMP _
- and GDP as _
- approp_
- riate_
- ly_
- ._

Main Duties and Responsibilities

  • Effectively interact with the other Logistics Quality managers/coordinators, Logistics Operations Managers, and stakeholders to maintain quality and help introduce new Quality improvements.
  • Liaise with clients on Quality Assurance and GDP related matters.
  • Manage deviations, client complaints and resulting CAPAs of _New _Zealand branch._
  • Prepare an internal audit schedule and perform internal audits including report preparation and assessment and tracking of associated corrective and preventive actions (CAPA).
  • Prepare an external audit program and perform audits of external service providers as part of the vendor selection process. Tracking and overseeing all commitments for actions or changes made by Marken from previous customer audits.
  • Host client audits and regulatory inspections and manage the audit report responses. Acting as Marken's main representative for customer audits, including the preparing of appropriate materials required within those audits.
  • Manage CAPA plans, collate CAPA data, and identify and implement quality improvement initiatives. Preparing the CAPA log for the site and overseeing activities that conclude on the appropriate closeout of all CAPA entries.
  • Ensuring that relevant customer complaints are dealt with effectively and completely.
  • Ensure the local implementation of Client Technical (Quality) and Service Level Agreements.
  • Identify relevant GDP/ Quality related training needs and deliver training where required.
  • Playing a Maestro Champion role for _New _Zealand branch._._
  • Manage the change control system for _New _Zealand branch._._
  • Assisting in the evaluation and qualification of Markendesignated vendors and/or outsourced activities, which including contractors, suppliers and LSP.
  • Ensuring the accuracy and quality of records and documents.
  • Keeping records of all qualification and validation activities performed for critical equipment.
  • Take a lead for any process improvement matter for _New _Zealand branch._
  • Train, manage and evaluate direct reports ( if any).

General
- _
Ens_ure that Marken Qu_ality System_ and GDP _p_rogram are implemente_d and maintained._
- _ Ens_u_re the ac_curacy and q_uality of records and docume_nts._
- _ E_nsu_re th_at _t_raining _for a_l_l personn_el involved i_n the processes of transpor_tati_on and s_tor_age _of medicinal prod_ucts_ is conducted and docu_mented._

  • Ensure that relevant client complaints are dealt with effective and completely.
  • Prepare the CAPA log for the site and oversee activities that conclude on the appropriate closeout of all CAPA entries.
  • Act as Marken's main representative for client audits, including the preparing of appropriate materials required within those audits.
  • Track and oversee all commitments for actions or charges made by Marken from previous client audits.
  • Assist in the evaluation and assessment of Markendesignated agents and/or outsourced activities.
  • Conduct selfinspection audits for the local or regional Marken facilities.
  • Keep records of all qualification and validation activities performed for critical equipment.
  • Ensure compliance with national and international standards and legislation.
  • Ensure timely and efficient management of records pertaining to the quality assurance group.

Acknowledgement


By signing in ZenQMS the jobholder agrees to comply with the requirements of the job description, and understands that failure to comply with the requirements may result in disciplinary action.

By signing in ZenQMS the line manager confirms the job description is a true and accurate reflection of the duties and responsibilities of the role, which has been fully explained to
- and understood by
- the jobholder.

Any changes to the job description must be agreed by the line manager and the jobholder.

Person Specification

Title:

Quality Coordinator

Reportable to:

Regional Quality Manager, APAC

Department:

Quality

Site:

New Zealand

**

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