Hc QA Supervisor (Facility Support)

UPS Türkiye

We are looking for a Healthcare QA Supervisor (Facility Support)  to work at UPS SCS Healthcare.

SUMMARY

The HC QA Supervisor (Facility Support) has day to day oversight of the facility quality system and their direct report activities.

JOB PURPOSE AND KEY RESPONSIBILITIES

·       Monitors and ensures compliance to UPS SCS site regulatory license requirements (e.g., GMP, GDP, ISO).

       -      Provides regulatory guidance to client and internal staff.

·       Execute process adherence checks (PAC) based on site schedule

·       Responds to client quality department inquiries or concerns.

·       Assesses quality risks and develops corrective and preventative actions (CAPA) to close identified gaps or concerns.

·       Supports the prompt execution of recalls and other market actions.

·       Creates, revise and reviews controlled documents and record templates (e.g. SOPs, Work Instructions, forms and manuals).

·       Supports change control management.

        -     Initiates, assesses and approves change controls.

        -     Develops quality related change action plan(s) and tracks to closure.

        -     Reports on delayed or late action plans.

·       Facilitates audits (regulatory agency, client/external and internal). 

        -     Hosts and coordinates audit.

        -     Develops audit response and corrective action plans based on feedback provided by auditors along with discussions from site operations and QA senior management.

        -    Tracks action plan to closure.

        -    Reports delayed or late action plans.

·       Supports projects for: 

         -   Growth of new and expanded facilities, clients and services. 

         -   Continuous quality management system improvements.

·       Conducts quality management system reviews.

         -    Track and trends quality system metrics.

         -     Reports metrics to site and senior HC compliance and operations management.

·       Provides support of investigation for non-conformance and customer complaints.

         -      Initiates, assesses and approves non-conformance.

         -       Develops corrective action plans in co-ordination with facility management and applicable subject matter experts (SME).

         -     Tracks action plans to closure.

         -     Reports late/delayed action plans.

·       Supports the qualification of all applicable vendors and suppliers.

·       Monitors and provides direction for control of environmental storage conditions (e.g. refrigeration, freezer).

·       Reviews, assesses and approves facility validation protocols and reports.

·       Tracks site employee training.

         -     Runs reports on late/missed training.

         -     Communicates late/missed training to employees and management.

KNOWLEDGE AND EXPERIENCE

·       Bachelor’s degree in science related discipline preferred

·       3 to 5 years’ experience in pharmaceutical or healthcare industry in a quality related role

·       Strong technical quality and regulatory affairs (QA/RA) knowledge

·       Experience with GMP and/or GDP guidelines

·       Experience with ISO 13485 and 90001 standard

·       Proficiency in English required (written and verbal)

·       Proficiency in second language preferred

·       Experience in managing staff

·       Positive leadership, influence and negotiation skills

·       Great personal communication skills

·       Strong verbal and written communication

·       Strong organization, time management and planning

·       Superior attention to detail

·       Basic proficiency in MS Word and Excel