Quality Compliance Manager

Rameda

Posted on 26 Nov

Experience

15 - 17 Years

Job Location

Giza - Egypt

Education

Bachelor of Pharmacy(Pharmacy)

Nationality

Any Nationality

Gender

Not Mentioned

Vacancy

1 Vacancy

Job Description

Roles & Responsibilities

Supervision, planning and implementation of all quality operations activities in order to optimize production within safety, legislative, environmental and company requirements.

Planning and conducting of internal auditing within company processes including closing of any raised non conformities.

Ensuring of the Quality Risk Management System inside the company to ensure effective identification, evaluation and controlling of the raised risks from different company processes.

Ensuring of the Contamination Control Strategy inside the company to ensure effective identification, evaluation and controlling.

Preparing for the external audits which conducted by different authorities inside the company.

To ensure compliance with cGMP standards at all times.

Ensures that all activities in his department are done according the relevant cGMP and ISO standards.

Participating in training process as trainer for related topics.

Lead and coordinate the daily activities of all subordinates within the quality compliance department.

Review and approve change control requests to ensure compliance with all applicable requirements.

Participating on team to investigate quality complaints to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution.

Participating in the facility upgrade processes.

Ensure that all approved CAPAs are tracked and communicated to all concerned parties.

Manage the follow-up of CAPA plans implementation and effectiveness.

Ensure that all received complaints are tracked.

Review and approve the investigation results related to customer complaints.

Desired Candidate Profile

PhD or M.Sc. in pharmaceutical sciences. Or relevant degree.

Analytical thinking, problem solving and communication skills.

Minimum of 15 years of experience in Compliance within the pharmaceutical industry.

Strong leadership skills with a track record of managing and developing teams.

In-depth knowledge of GMP, GLP, and relevant regulatory guidelines.

Excellent problem-solving and decision-making abilities.

Strong organizational and project management skills.

Exceptional attention to detail and accuracy in documentation.

Effective communication and interpersonal skills.

Company Industry

Department / Functional Area

Keywords

  • Quality Compliance Manager

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