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Manager - Quality Compliance (LIMS)
Piramal Pharma
posted 4hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- To have good understanding and knowledge on LIMS application functionalities and its integration with other systems.
- To provide SME support for the implementation of LIMS (Laboratory Information Management System) across sites and support the key decisions for the changes that required in the workflow of the system from Quality and e-compliance perspective.
- To support the validation of LIMS application (specifically). Additionally, to support the validation of Enterprise Systems, LMS (Learning Management System), VLMS (Validation Life Cycle Management Systems) and other applications systems to comply with regulatory guidelines.
- To define validation strategy and provide inputs to validation planning for projects; along with the review of validation/qualification deliverables of the assigned project/system in line with the organizational SOPs & adhering to company procedures and regulatory expectations.
- To ensure infrastructure (Network, Servers, Cloud, Database) are qualified as per required Quality standards and required documents are in place.
- To support the various phases of Computer System including Planning, Implementation, Maintenance, and Retirement activities by ensuring compliance with internal/external regulatory requirements.
- To review other QMS documents e.g. Change control/Deviation/ CAPA/Incidents-Discrepancy/User access forms in line with the organizational/site specific procedure.
- To communicate/discuss the identified gaps during the GxP computerized system assessment to responsible team. Coordinate with the relevant IT team for the compliance/closure of the identified gaps, incidents, deviations.
- To guide and train IT & Business teams at Site for CSV, relevant areas of Compliance and Validation for GxP IT and electronic systems, Data Integrity, and Regulatory Compliance activities.
- To perform periodic and audit trial review of the GxP application system as per defined frequency along with the relevant stakeholders.
- To support sites to ensure audit readiness and ability to represent the validation package of enterprise GxP application including LIMS during regulatory audits and can be able to perform DI Audits at site.
- To coordinate & build good working relations with Site/business users, Subject Matter Experts (SMEs) and IT operations team, Manage vendors / partners / support teams.
Employment Type: Full Time, Permanent
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People are getting interviews at Piramal Pharma through
People are getting interviews through
(based on 62 Piramal Pharma interviews)
Job Portal
Referral
Walkin
Company Website
Campus Placement
Recruitment Consultant
29%
16%
16%
13%
8%
3%
15% candidates got the interview through other sources.
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What people at Piramal Pharma are saying
Rating based on 1 Quality Manager
review
Anonymous · Quality Control
in Hyderabad/Secunderabad, Telangana
Likes
HR policy and transportation services
Dislikes
Higher Management and their control
Read 1 reviewQuality Manager salary at Piramal Pharma
reported by
4
employees
with 14-17
years exp.
₹11.2
L/yr - ₹16.4
L/yr
11%
more
than the average Quality Manager Salary in India
View more details
What Piramal Pharma employees are saying about work life
based on 857 employees
Flexible timing
Monday to Saturday
No travel
Day Shift
Piramal Pharma Benefits
Submitted by Company
Free Transport Soft Skill Training Job Training Health Insurance
Submitted by Employees
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Piramal Pharma Mumbai Office Location
Mumbai, Maharashtra Office
Headquarter
Kamani Junction, LBS Marg, Piramal Ananta, Agastya Corporate Park, Kurla, Maharashtra 400070, IN
Mumbai, Maharashtra
400070
400070
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