« Вернуться к результатам поиска

Repack and Batch allocation coordinator (Координатор по перепаковке и распределению поставок) - вакансия 131582

ТОО ГСК Казахстан

Дата обновления: 23.05.2018

Город: Алматы

Тип занятости: Постоянная



Текст вакансии:

Responsibilities:

• Manage all matters pertaining to GxP, Regulatory and QMS Compliance for repacking procedures to ensure timely QA approval before initiate any repacking activity as well as to ensure timely QA batch release of repacked orders before distribution. Ensure documentation of batch records including repack protocol and retention samples, where applicable.

• Defines scope for repacking.

• Raises repack request forms and prepares technical specifications for AW components for repacking, leaflets and stickers, consolidates information from all functions, registration, logistics, marketing.

• Ensure all requested assessments and approvals are obtained in repacking request form

• Accountable for AW components in repacking process. Responsible for preparing stickers, checking texts, checking samples, ensuring texts are checked by all involved functions, approving repacking components in Zink, providing approved valid repack components (stickers).

• Responsible for communication and alignment of repack process among functions, including for communication and coordination of process with respective colleagues.

• Accountable for the regular update of the repack tracker by relevant departments (registration, logistics).

• Conducts necessary meetings on monthly basis with regulatory, marketing, supply, quality for timely repack planning and alignment between functions.

• Conducts necessary trainings for respective functions on repack process.

• Periodic self-inspections and audits of repacking operations.

• Batch release approval for repacked products, where applicable.

• Batch release of printed components, where applicable.

• Assist in the batch assessment/release process within the regulatory and corporate framework to ensure timely release of products.

• Evidencing of CoA/ translation.

• Batch allocation of current shared CIS stock and replenishments between markets depending upon AWs validity in each market taken.

• Verification of batches selected in the customer’s invoice for possibility of shipments based upon proper batch allocations.

• Accountable and regular update of Duty of Care Excel file in place to reflect dynamics of regulatory changes reflected in time and in full based on RA team notifications.

• Updates on stock situation, OOO and POS driven by batch-allocation issues connected with AW changes.

• Cross-functional collaboration for full alignment in ordering process.

Requirements:

  • Higher education;
  • Minimum of 1-2 years’ experience within the Pharmaceutical / Consumer Healthcare Industries, preferably in the capacity of a quality specialist;
  • Knowledge of regulated requirements pertaining to GMP/GDP;
  • Understanding of and experience in quality assurance systems particularly in areas of batch release, product incidents, control and performing audits;
  • Knowledge on effective quality documentation system;
  • Professional written and verbal communication skills. Able to deliver positive and pro-active communication and foster excellent working relationships with stakeholders at any level of the organization;
  • Ability to influence and motivate stakeholders and any level of the LOC organization;
  • Analytical mind, good attention to detail and problem solving skills within a structured process
  • Good team player – works well in cross-functional teams;
  • Good time management skills, with ability to multi-task and work under pressure;
  • Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods;
  • Strong interpersonal and negotiation skills;
  • Ability to self-motivate and be resilient and focused under pressure;
  • Flexible thinking – able to challenge and see views from different perspectives;
  • Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook;
  • Able to work effectively in English.

Conditions:

  • Competitive salary;
  • Medical insurance;
  • Compensation package.


Контактные данные:

Откликнуться