Quality Assurance Senior Supervisor

At Hikma we put better health within reach, every day in more than 50 countries around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more info Disclaimer: EMPLOYMENT RECRUITMENT FRAUD ALERT Please be advised that the Hikma Pharmaceuticals Group does not ask its employees or prospective employees to wire any money either to its bank accounts or to any third party, and does not conduct employment interviews via any social media platform, Google Hangouts, Yahoo! Messenger, text message, or e-mail. Unfortunately, employment scams are increasingly common and it is important to remain vigilant when conducting a job search. For more information about these scams, see the UK National Fraud Intelligence Bureau’s website and the US Better Business Bureau’s article on the subject. If you receive a request to send money through any means or a request for personal information from anyone claiming to be a Hikma recruiter, DO NOT REPLY. Instead, please forward the communication(s) to us at [email protected] so that we may provide it to relevant law enforcement agencies, as appropriate.

Website

http://www.hikma.com Job Purpose:

To lead and supervise quality operations team for both sterile and non sterile plants to ensure quality by design during different in process steps during manufacturing, maintaining high quality level and quality culture in the work environment.

Duties & Responsibilities

• Recommend improvements to departmental policy and directs the implementation of procedures and controls covering all areas of Quality activity so that all relevant procedural/legislative requirements are fulfilled while delivering a quality, cost- effective service to customers.
• Supervises the day-to-day operations of Quality Assurance department to ensure that work processes are implemented as designed and comply with established policies, processes and procedures.
• Reviews and approves documents generated by the department, in order to provide approvals on deviations, CAPA, and annual product review reports.
• Participates in quality risk management procedures, in order to manage and maintain the day-to-day change control process for product and process related information.
• Supervises the creation and revision of batch record documents to support product development and product implementation.
• Participates in developing divisional procedures and guidelines to develop responses to corporate, regulatory, and third-party audits findings
• Utilizes data from QA Trending for Complaints, Deviations, CAPA, and Risk Assessment to identify and escalate Product Quality risk and monitor QA metrics as appropriate.
• Reviews and investigates specific cases for quality issues at the supplier site during audits to support Hikma Quality units
• Conducts gap analysis for Hikma functions actual and potential performance to facilitate harmonizing the system within the group.
• Organizes and supervises the activities to ensure that all work within a specific area of Quality activity is carried out in an efficient and procedurally compliant manner
• Complies with all relevant safety, quality and environmental management policies, procedures and controls to ensure a healthy and safe work environment.
• Supervise and control batch release team to ensure effective batch records review according to the relevant procedure and all batches are released according to the relevant procedures meeting required shipping plans.
• Complete oversite and leadership for the IPC team for all sterile and non-sterile plants, dealing and taking appropriate decisions for all trouble shooting and incident situations.
  
  

Qualifications

• Bachelor’s degree in pharmacy or relevant.
• At least 8 years of experience in the pharmaceutical industry.
• Excellent organizational and leadership skills
• Sterile Pharmaceutical background is a must.
• In depth understanding of Quality Assurance procedures
• Job Location: Bady City