QA Validation Specialist

2 weeks ago

مصر, Egypt Multicare Egypt for Pharmaceutical Industries Full time

**Multicare** Egypt for Pharmaceutical Industries is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, gender identity or expression, age disability, or other characteristics protected by prevailing regulations, practice or customs/traditions.

**Multicare** is a well-established Pharmaceutical Company with diversified scope in both manufacturing and marketing of pharmaceutical products, supplements, cosmetics and medical devices. Multicare has +21 years of prominent existence in the local market and has almost +69 products marketed and more to come through the pipelines. Multicare Egypt for Pharmaceutical Industries is the manufacturing facility, which located at the Industrial Zone - New Cairo and its HQ at New Cairo as well. We are one of the fast growing Pharmaceutical Companies in the market which has strong ambition and aspiration to be one of the key players not only in Egypt but also within the region.

Our international alliances are effective in different countries, including Saudi Arabia, United Arab of Emirates, India and New Zealand with future aspiration to extend more business associations and affiliations in near future to further markets. Recently Multicare Poland has been launched which will be the entry port of the business to the European Union (EU).

**VACANCY**:
We are seeking a Validation Specialist to join the Quality Assurance Team as per the following details:
**Designation**: QA Validation Specialist

**Location**: New Cairo HQ

**Job Grade**: qAv1/qAv02

**Reporting**: QA Section Head

**Job Purpose**:
To ensure the proper implementation of quality system and GMP, to prioritize, sample, test and release bulk/semi-finished products to strict timescales, in order to support the business requirements.

**A. Essential Duties and Responsibilities**:

- Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
- Provide inputs to and administration of the site master validation program as well as assist in maintaining the site validation master plan
- Issue Validation Master Plan
- Develop and monitor the implementation of annual calibration plan
- In case of faults, doing the required deviation & begin the corrective actions.
- Work actively with cross-functional teams aiming to resolve challenges through appropriate set of corrective actions and timely completion of these reports
- Withdrawal of samples and initiating the process validation study protocols for all products
- Initiate and execute campaign hold time studies, cleaning validation protocols and reports and bulk products hold time studies
- Prepare validation activities plans & issue protocol that comply with regulatory requirements & company policy
- Prepare NCR reports, deviation and NCR risk assessment & review CAPAs relevant to validation activities
- Prepare NCR reports, deviation and NCR risk assessment & review CAPAs relevant to validation activities.
- Register & evaluate identified current or potential quality risks, suggest with key stakeholders proper mitigation actions & re-evaluate risk after their implementation
- Provide periodical reports to superior with appropriate analysis regarding all validation updates to ensure effective & accurate updated records

**B. Qualification/Knowledge/Experience**:
Level of Education: Life Science Degree

Experience : Experience of working in a GMP environment

Language : Fluent English proficiency is mandated

IT Literacy : Professional knowledge of MS-Office

**C. Competencies and Behaviors**:

- Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Highly proficient in the use of key analytical equipment.
- Credible and confident communicator (written and verbal) at all levels.
- Ability to achieve and maintain high standards with meticulous attention to detail.
- First class planning, organizational and time management skills.
- Ability to work accurately in a busy and demanding environment, adhering to strict deadlines/timescales.

**What we offer**:
With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life

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