Supervisor, Quality Control

5 meses atrás


Sintra, Portugal Hikma Pharmaceuticals PLC Tempo inteiro

Founded in 1987 in Jordan, by Mr. Samih Darwazah, Hikma's purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve.

In 2000, we successfully passed FDA inspections for our manufacturing plants in Portugal. Our Injectables business also expanded into the lyophilized segment of the injectables market with the acquisition of a specialized manufacturing plant in Italy, and we moved into the oncology market with the acquisition of Ribose Pharm and Thymoorgan in Germany.

In 2005, the Group was listed on the London Stock Exchange, raising gross proceeds of US$124 million. A successful initial public offering enhanced our flexibility to grow the business both organically and through acquisitions. From 2005 onwards, we have expanded our presence in the MENA region and also made significant acquisitions in Europe and the United States to strengthen our Injectables business.

Currently, we are looking for a **Supervisor, Quality Control (M/F)**, to integrate our Quality Control department (M/F).

**Main responsibilities**:

- Supervise and plan the correct execution of required analytical work and completion of relevant documentation, verifying accuracy of generated results, reports and CoAs;
- Supports the management of critical documents and CAPA in addition to the preparation of quality management and audit reviews;
- Work closely with other quality control and quality unit management and personnel to maintain laboratory compliance to procedures and in place, guidelines and regulations;
- Review laboratory notebooks and raw data, to ensure the completion and accuracy of information and generated data;
- Approve Quality control CoAs for raw materials, packaging materials, and final drug products batches on the Informatic systems Labware LIMS and Sage X3;
- Evaluate change control for primary packaging material and utilities (WFI, nitrogen, compressed air, etc);
- Responsible for training the team members in the procedures described in Wet-Chemistry training plan.

**Profile**:

- Academic degree in Chemistry, Chemical Engineering or relevant fields
- +5 years QC work-related experience or similar field in a regulated analytical Lab with cGMPs environment
- Demonstrated knowledge of working in an analytical lab environment, of the cGMPs, and ability to generate, review and follow SOPs and policies
- Skills to perform and evaluate feasibility for required analytical techniques
- Competence to operate and troubleshoot the associated equipment and software
- Proficiency in English, written and spoken
- Project management skills
- Leadership, interpersonal, teamwork and problem-solving skills
- Capacity to support and follow directions, attention to detail meet deadlines and multi-task

**What we offer**
- Base salary
- Discretionary bonus
- Meal
- Life insurance
- Health insurance

If you think this is a good opportunity for your professional career, join us and contribute to better health, within reach, every day.



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