Associate I, R&D Quality Systems (QMS)

alcon; Bengaluru; On-site; INR 600,000 - 800,000; Full time

Job summary

Alcon in Bengaluru, India, is seeking an R&D QMS Administration professional to ensure training and document control systems are audit-ready for FDA and ISO requirements. The role provides administrative support for training and document control activities and instructs users to ensure efficient system administration.

The candidate will write SOPs and training materials, maintain local SOPs/forms, support QMS documentation, and act as SME for Document Control and Training.

Qualifications

• Experience with QA documentation and training records.
• Familiarity with FDA/ISO requirements for QA systems.
• Ability to generate training plans in the LMS and track compliance.
• Experience in change control and continuous improvement activities.

Responsibilities

• Write new SOPs and Training Materials to support R&D and QMS activities.
• Establishes and maintains local SOPs/Forms, and Training Materials.
• Assist R&D personnel with technical writing support for QMS documentation such as NCR investigations and CAPA records.
• Serve as the R&D QMS Document Control and Training SME for audits.
• Generate training plans in the LMS and assign training.
• Oversee training plan tracking, compliance metrics, and notifications for due training.
• Process changes/documents per governing policies and procedures.
• Provide QA approvals for document revisions and changes.
• Audit changes/documents and drive improvements in productivity and compliance.
• Lead QMS/compliance projects related to Document Control.

Job description

The R&D Quality Management System (QMS) Administration personnel is a QA function responsible for ensuring the QMS systems of training and document control are maintained audit-ready to FDA and ISO requirements, as well as corporate policies and local procedures where established. The role provides administrative support for training and document control activities and instructs users to ensure efficient administration of the systems.

Direct R&D QMS Support

Write new SOPs and Training Materials to support R&D and QMS activities where requested. Establishes and maintains local SOPs/Forms, and Training Materials where needed.

Assist R&D personnel with technical writing support for QMS documentation, such as nonconformance investigations and corrective action records.

Primary AGS SME for the R&D QMS systems of Document Control and Training for supporting R&D External and Internal Audits.

Training Administration

Generate training plans in the Learning Management System (LMS) to meet functional needs of R&D.

Process training plan assignments ensuring job specific and core training requirements are met.

Will support change control and continuous improvements activities for the training system, as needed.

Conduct regular training/skill building/practice sharing activities to help the R&D sites: simplify training plans, perform efficient data entry/traceability of training, and quickly assess training system impact and plan out change control tasks associated with training.

Oversee tracking, trending, and reporting compliance metrics for the Training system: Alcon Scorecard, Management Review, workload volumes and various notifications. Participate in routine meetings with Alcon R&D QMS site staff to communicate metrics.

Initiates and Oversees the annual periodic review process and continuous improvement activities for R&D training items within the LMS.

Ensures routine notifications to R&D management personnel are provided for past due and pending training assignments within the LMS.

Document Control Administration

Generate and Processes changes/documents in accordance with established governing policies and procedures.

Performs QA approvals for: Document obsolescence (when accompanied by an approved change request), New/revised Work Instructions, Administrative Document Revisions, and Administrative approvals as defined by procedure.

Auditing of changes/documents ensuring proper resolution of noted deficiencies.

Acts as a Quality Assurance SME for the document control processes and assists with driving initiatives to identify and solve procedural deficiencies to improve productivity and compliance.

Lead QMS and compliance project/ initiatives related to Document Control, as requested.

Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.