Associate I, R&D Quality Systems (QMS)
Alcon · Bengaluru · onsite · Posted 44d ago
Undisclosed2–6 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
The RD 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 RD QMS Support
- Write new SOPs and Training Materials to support RD and QMS activities where requested. Establishes and maintains local SOPs/Forms, and Training Materials where needed.
- Assist RD personnel with technical writing support for QMS documentation, such as nonconformance investigations and corrective action records.
- Primary AGS SME for the RD QMS systems of Document Control and Training for supporting RD External and Internal Audits.
Training Administration
- Generate training plans in the Learning Management System (LMS) to meet functional needs of RD. 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 RD 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 RD QMS site staff to communicate metrics.
- Initiates and Oversees the annual periodic review process and continuous improvement activities for RD training items within the LMS.
- Ensures routine notifications to RD 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.
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
Find Jobs for Employees
Find Jobs for Contingent Worker
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.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Administrative SupportQAAuditinglmstechnical writingauditsChange ControlScorecardQuality SystemsQuality AssuranceAdministrationcomplianceData Entryquality managementProcess Training
About Alcon
Alcon
Medical Equipment
2.2k+
employees
1945
81 years old
Fort Worth,Texas
United States
About
A global leader in eye care, offering innovative surgical and vision care products while prioritizing research and development to meet evolving patient needs.
Industries
Medical EquipmentInternetAnalytics & KPO
Employee ratings
581 reviews
3.8/ 5
Culture
3.7
Career growth
3.0
Work-life
3.8
Employees rate it well for
Work Life Balance71Work Culture67Senior Management50Salary48Job Security36
Find them on