Associate Specialist, Quality Operations

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Job Details

Summary of Role:

Under general direction of the Regional Quality Manager plays an important role to assure the local compliance with World Courier policies and procedures.

Responsabilities:

• To monitor and ensure that all Company Policies and Procedures are followed by World Courier the assigned country.

• To follow Quality Assurance Policies and Procedures, interpreting and implementing Quality Assurance Standards.
• To coordinate the actions to be taken with other QA representatives belonging to In-country Quality department.
• Ensuring and improving the quality of the service provided to the clients by working close to the operational team.
• To participate in the CAPA and complaint process, including reporting to global QA any deviations or potential problems, participate in the investigation, support with the generation of reports, and tracking deviations and actions as described on the specific internal guidelines.
• Responsible for coordinating all internal and external audits and regulatory inspections (ISO 9001, ISO 14001, GDP and Client) and coordinating all audit replies. Responsible for preparing all required documents and information to present during External audits and ensuring that a World Courier Confidentiality Agreement has been signed.
• Responsible for quality related activities included but not limited to CDA and Quality Agreements.
• Responsible for reviewing Local Standard Operating Procedures (SOPs) and Work Instructions (WI) to ensure the service standard and qualities are met.
• Establish appropriate training material and conduct training for general quality topics.
• Responsible for subcontractor and supplier qualification in close cooperation with the subject matter expert and the local operational team.
• Assist in setting up and to participate in Risk Management and Change Control processes.
• Enter all local relevant data into QA SharePoint to allow for timely quality metric generation.
• Assist the country in ensuring compliance to World Courier and country specific documentation / retention requirements.
• Serve to assist as first line contact in order to inform the company about regulatory updates that might impact World Courier service.
• Overview calibration, maintenance and qualification program according to internal guidelines, supporting the local facility representative and QA manager technical compliance.
• To identify along with local team, the need of local procedures and implement Local internal guidelines in accordance with operational and technical needs and local regulations, respectively.
• Responsible for quality related activities related to the Self-Inspection Report. (Transport)
• To review the information on the temperature periodic report for all temperature controlled areas. (Transport)
• To support any changes/developments initiated by the Regional /Global Quality Management.
• Any other quality responsibilities assigned by Regional/Global Quality Management.
• Assure that World Courier Depot License(s) as well any other regulatory documentation is/are properly in place and updated. (CSS )
• To contact clients whenever required in order to communicate expansions, depot moving process, regulatory updates clarifications, etc. (CSS)
• To overview that cleaning program is properly implemented and documented. (CSS)
• Communicate to Management team and QA Department, along with Depot and /or Warehouse Manager and Depot Pharmacist, exceptional needs for the storage of products required by clients/ sponsors. To provide local regulation background to support Management and QA team decisions. (CSS)
• To ensure that physical batch packaging records are retained and archived. (CSS)
• Perform that spot checks (as described in WC internal guidelines) to other operative activities are performed in order to monitor that WC procedures and protocol/program instructions are properly performed by depot staff. (CSS)
• To support recalls and mock recalls conducted in the Depot In accordance with applicable internal guidelines. (CSS)
• To act as witness during the destruction process for stored products, e.g. IMP/Clinical Trial Material or commercial products when required. (CSS)
• Review deviation assessment which are documented as part of the periodic temperature reporting for all temperature-controlled areas. (CSS)
• Review validation documentation (e.g. MARS, equipment, facility) and to assure that the validation is performed according the Validation Master Plan. (CSS)
• To clarify discrepancies and deviations from SOPs and study / client specific instructions and implement Corrective and Preventative Action Plans in order to correct abnormal procedures (CAPA Complaint Process). (CSS)
• To complete inbound quality checks and confirmation of client’s disposition in approval process for 3PL. (Commercial only)
• To review and authorize the change of product status following client instructions and within the scope of applicable Internal Guidelines. (Commercial only)
• To maintain the Security Control System -BASC (BOG).
• To act as the Technical Director of the organization in front of the Ministry of Health and its dependencies (Secretaria de Salud).
• To act as the back up of the Technical Director of the organization in front of the Ministry of Health and its dependencies (INVIMA, FNE & Secretaria de Salud).
• To act as the back up of the Technical Director of the organization in front of the Ministry of agriculture and social development and its dependencies (ICA).

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Education:

• Requires a Degree in pharmaceutical chemist.
• Basic understanding of Quality Management processes (e.g. ISO 9001)
• Basic GxP expertise (e.g. local GMP, GDP and regulatory aspects)
• 1 to 2 years working experience in Quality environment.

Work Experience:

• Logistics or Pharmaceutical Industry Experience
• 2 years of experience in quality systems support, document management, or a related field required.
• Ability to perform routine professional tasks under supervision and deliver accurate work products with audit-ready records.

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Affiliated Companies

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned