QMS Officer

Job Purpose

As the QMS Officer, you will play a key role in maintaining and continuously improve quality systems, ensure regulatory compliance, and support risk-based decision-making for consistent product quality across all operations., you will:

* Ensure QMS compliance and timely closure.
* Ensure documents and record control.
* Ensure product compliance to the dossier.

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

IPQV (Morocco Plant)

* Carrying out all the assigned functions within the Quality Assurance Department.
* Participating in creating, reviewing, approving and monitoring quality systems, procedures, specifications and amendments. Suggesting for Improvement, continuous review and upgrading of existing SOPs, specifications, test methods and work systems.
* Ensure that the requirements of Current Good Manufacturing Procedures (GMP) are fulfilled in all the procedures and are followed.
* Critically examining the environment with a view to minimizing product contamination.
* Ensure strict adherence to safety, health and environment.
* To identify areas of wastage and areas of work simplification.
* To control and monitor technology transfer activities.
* 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 are carried out and adopted per the need.
* To operate Softwares as per roles and rights provided in application.
* To ensure retention and destruction of documents and records are done as per SOP.
* To ensure availability of approved product dossier and to ensure gap analysis is performed between registered documents and current documents before the launch of the product.
* Review and approve the annual product quality report of all drug products and its relevant data / records / trends to assure that products are meeting consistently quality standards. And recommend improvements in product quality as applicable.
* Review of different logs to production, packing, stores, Quality Assurance, Engineering and Quality control.
* 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 and to ensure implementation of change.
* Conducting unit operations and ensuring the unit operation procedure is followed.
* To ensure schedules are prepared and followed as per respective SOP.
* To ensure and participate in investigation of deviations, complaints, out- of specification / out of trend and batch failures are appropriately performed and documented.
* To review and approve investigation of deviations, complaints, out- of specification / out of trend and batch failures and related corrective and preventive actions.
* To ensure appropriate corrective and preventive actions based on the results of the investigations are identified and implemented.
* To monitor and participate in recall related activities.
* To ensure pest control activities are done appropriately and are documented.
* Monitor and ensure that all QMS i.e. Deviation, change control, Complaints and CAPA etc. are followed as per approved procedures.
* Monitoring and preparation of action plan as per quality metrics.
* To review or perform activities related to risk assessment.
* Conducting Quality Management Review meeting and monitoring completion of action items and plans from review meeting.
* To provide compliance to the observations identified in Audits.
* To ensure notification of OOS are sent to customer or Regulatory Affairs by referring relevant customer QTA.
* Complaints, Deviation and CAPA as per the roles and responsibility assigned.
* Approval of Change Request.
* Any other assignment allocated by Quality Assurance Manager.
* Major Challenges
* Managing complexity across multiple areas with different requirements (QMS, training, APQR).
* Aligning cross-functional teams (Production, Quality control, Warehouse) on planned QMS , investigation related to their respective areas.
* Maintaining audit readiness and compliance .

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

* Number of FP batches released: 20 Batches/month.
* Non-conformance, deviation, OOS/OOT to be closed within 30 working days.
* Training for the teams.
* Shifting to fulfil urgencies.

Key Decisions

Decisions

Recommendations

Update of QMS SOPs

Base decisions on regulatory guidelines (cGMP, ICH), audit outcomes, and Cipla standards

Approve or reject change requests (facility, product, system, equipment)

Impact analysis and risk assessment; involve cross-functional teams

Document & Record Control

Identify user department according to SOP usage and destruction of document according to SOPs requirements

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 guidelines.
* Analytical, organized, and solutions oriented.
* Able to collaborate cross-functionally.
* Attention to detail
* Strong problem-solving and decision-making ability