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Stability Analyst (On -going Stability)

Julphar

Posted on August 14, 2019

2 - 3 years United Arab Emirates - United Arab Emirates

Bachelor of Science(Chemistry). Any Nationality

Opening 01

Job Description

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Stability Analyst will ensure that the stability testing of all products has been performed according to standards guidelines (ICH/FDA/GCC and WHO). The position will be responsible for the stability testing of Drug products and drug substances, recording data, evaluating and reporting data using prescribed procedures.
Key responsibilities & Accountability:
Responsible for the ongoing/commitment stability testing of all drug products/drug substances.
Monitoring the conditions (temperature/humidity) of stability chambers.
Updates the stability chamber records and corrective actions (in case of alarms).
Accountable for the OOS Investigations.
Maintaining stability records and logbooks.
Monitors and maintains the calibration of analytical equipment.
Take part of writing stability protocols, reports and Standard Operation Procedures.
Conducts pre-training and post-training of the new analyst to ensure the quality of learning.
Follows the stability protocols to meet the standards of the organization.
Follows the STM's and FPS, SOP's, GMP, GLP, and GDP sets by the department and organization.
Follows all instructions given by the Head QC/Director as per the set rules and regulations of the Company.
Qualifications:
- Education
Bachelor/Master in Chemistry or Pharmacy
- Experience:
Has at least 2-3 years of relevant experience in stability lab (QC/R&D) of pharmaceutical field.
Has experience in providing stability testing support of drug products and drug substances.
- Training:
Key Competencies:
Has excellent oral and written communication skills. Ability to work under pressure / crisis situations and results oriented. Ability to work in second/third shift.
Technical Competencies:
Has in-depth knowledge of drug products and quality.


Pharma / Biotech / Clinical Research

IT Software

Keywords

Pharma Analytical Pharmacy GMP GLP Monitoring QC Head Chemistry Training Director

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Julphar

Established in 1980 in the UAE, Julphar Gulf Pharmaceutical Industries is the largest generic pharmaceutical manufacturer in the Middle East and North Africa. Beginning its journey with the first stand-alone facility that produced 5 products, Julphar now operates 15 globally certified manufacturing facilities. Distributing medicines to more than 40 countries globally, the company maintains a broad range of product portfolio that includes categories such as Pediatric Primary Care, Wound, Anemia and Women Care, Cardiopulmonary Care, Consumer Care, Adult Primary Care, Gastro Care and Pain Management. The company holds the vision to be recognized as the leader for pharmaceutical products and contribute to a better healthcare in the Middle East and Africa region.



Julphar’s 13 facilities are based in the UAE while other manufacturing units are available in Bangladesh, Ethiopia and Saudi Arabia as a part of its international expansion plan. In 2012, the company also launched the only one of its kind Active Pharmaceutical Ingredient (API) manufacturing facility in the Middle East named as Julphar Diabetes, which supported its positioning among the largest manufacturers of insulin in the world. Julphar has bagged several awards and ISO9001 and ISO14001 accreditations. It works closely with regulatory bodies, such as the US Food and Drug Administration (FDA) and the UAE Ministry of Health (MOH) to ensure that all their practices are aligned with the international requirements.



Julphar employs around 3,000 people around the world and believes that its corporate results are achieved due to its dedicated employees. Working for Julphar offers an opportunity for career and personal development.

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