Laboratory Validation Officer

Job Purpose

As the section head validation, you will play a key for ensuring that all validation/ qualification activities, and compliance processes meet regulatory and internal standards. This role provides critical quality oversight across qualifications, validation, and risk assessment area to ensure compliance with applicable guidelines, you will:

* Ensure the planning, execution, review, QA support and lifecycle management of validation /qualification and studies related activities.
* Oversee storage condition monitoring and qualification, including temperature mapping, excursion investigations, and compliance with product-specific requirements.
* Establish, facilitate, review, and maintain quality risk assessments for product, facility, etc ...

This role reports directly to the QA Manger and requires close collaboration with operational department, IPD team in Inda, and transferring unit in case transfer tech.

Key Accountabilities

Accountability Cluster

Major Activities / Tasks

Validation and Qualification (Morocco Plant)

* Ensure strict adherence to safety, health and environment.
* Carrying out all the assigned functions within the Quality Assurance Department.
* Ensure that the requirements of Current Good Manufacturing Procedures (cGMP) are fulfilled in all the procedures and are followed.
* Critically examining the environment with a view to minimizing product contamination.
* To identify areas of wastage and areas of work simplification.
* Identification of training needs and imparting training with respect to cGMP, Safety, Hygiene,
* application and principles of Quality Assurance. To ensure that the required initial and continuous
* training of department personnel is carried out and adopted per the need.
* To operate QA software as per roles and rights provided in application.
* To ensure retention and destruction of documents and records are done as per SOP.
* Creation, review, evaluation, implementation and closure of change requests related to systems,
* facility, others, Equipment, instruments, product and document and study of impact related to
* changes (validation and Qualification related changes) and to ensure implementation of change.
* Conducting unit operations and ensuring the unit operation procedure is followed.
* To ensure schedules are prepared, followed and completed as per respective SOP.
* To participate in investigation of deviations and review of the deviation related to validation and
* Qualification.
* To ensure appropriate corrective and preventive actions based on the results of the investigations are
* identified and implemented.
* To review or perform activities related to Quality Risk Management. Review of risk assessment and to ensure completion of risk assessments as per the schedule.
* Ensure that all Validations and Qualifications are properly planned, conducted and documented.
* To review and approve validation and qualification records and documents. To ensure all validations
* are properly planned, executed and documented.
* Execution and participation in validation and qualification activity whenever required.
* To ensure preparation and updation of schedule as per VMP and execution of activities as per schedule.
* To ensure the completion of activities related to Computerized System Validation, Qualification and
* cleaning validation as per the schedule.
* To ensure the completion of cleaning validation activities.
* To review SOP’s, Protocols, Reports and specifications.
* Preparation, updation and maintenance of various lists in the department.
* Any other assignment allocated by Quality Assurance Manager.

Major Challenges

* Managing complexity across multiple areas with different requirements (Qualification, risk assessment, product quality review).
* Aligning cross-functional teams (Production, Quality control, Warehouse) on planned validation and studies planned.
* Maintaining audit readiness and compliance for Qualification and validation activities.

Key Interactions

Internal

External

* Supply Chain Team (S,C,I)
* Regulatory and QA Team (S,C,I)
* QC team (S,C,I)
* Manufacturing (S,C,I)
* Bracketed information taken from Divisional Accountability Matrix/RASCI

NA

Dimensions

Ensure Qualification & Validation for all available equipment (69 main equipment) Systeme and Process and cleaning validation, and for future equipment, system and process added.

Risk Assessment preparation for product manufactured (4) facility (1) DI.

Examination that Storage Conditions for all areas (5 areas) are maintained according to specification and mapping studies for those areas are compliant.

Key Decisions

Decisions

Recommendations

Ensure Qualification and validation are up to date

Regularly review Qualification / validation planning

Coordinate the execution of Qualification / validation / studies activities

Align with department to execute protocols as per design

Prepare the risk assessment

Review all potential risk with cross functional team

Comments

Skills & Knowledge

Educational Qualifications

* Master’s degree in quality, or related field.

Relevant Experience

* At least 2 to 6 years in Qualification /validation roles, in pharmaceutical industry.

Skills

* Fluent in French and English (spoken and written).
* Advanced Excel, Minitab user.
* Strong understanding of statistical tools, and GMP guidlines.
* Analytical, organized, and solutions oriented.
* Able to collaborate cross-functionally.
* Attention to detail
* Strong problem-solving and decision-making ability