Overview
General Manager – Corporate Quality Jobs in Gurugram, Haryana, India at Sentiss Pharma Pvt. Ltd.
Title: General Manager – Corporate Quality
Company: Sentiss Pharma Pvt. Ltd.
Location: Gurugram, Haryana, India
Summary
Qualification & Experience : M.Pharm /M.Sc with 15-18 Years of experience
Responsibilities
• To be responsible for implementing and managing the Quality Management System at Head office, SRC and Provis.
• To ensure the compliance of Quality in R & D and to approve all the technical documents.
• To be also responsible for Quality oversight through Quality Plan at SRC, Plant and CMO.
• Stay abreast with GMP requirements and on time training within the team as well as cross functional teams.
KRA's
• Management of state of control for QMS elements at Plant, SRC and CMO through Quality oversight.
• Effective implementation, monitoring and maintenance of the Quality Management System (QMS) at HO, SRC and Provis.
• On time availability of approved specification and STP to QC.
KEY RESPONSIBILITIES:
1) Strategic Plan implementation for CQA and R&D QA:
- To ensure implementation of strategic decisions related to CQA and R&D QA.
- Introduce changes to bring processes up to speed, systems to ensure simplification and automation where required and resources to build the required capabilities.
2) Operations – CQA:
• To ensure smooth and target error free functioning at CQA and R&D QA. To
provide support and guidance, in consultation with Head Corporate Quality
Operations. To identify areas of improvement internally and effective
implementation of new initiatives, which are the outcome of various audits and
third party experts review.
• To ensure qualification and requalification of vendors (RM, PM, GMP
consumables, CMO, CTL etc.) and contract development labs as per approved
schedules.
• To ensure ISO certification audits are performed on time successfully and ensure
compliance.
• Management Representative Responsibilities (For Head Office) to ensure:
✓ The quality management system conforms to the requirement of ISO
standards.
✓ Processes needed for the quality management system are established,
implemented and maintained.
✓ Reporting on the performance of the quality management system and on
opportunities for improvement, in particular to top management
through Quality Metrics.
✓ Review and approval of SRC documents (Technology Transfer Documents
of PD and PK i.e, PDR, MFR, BOM, PFC, Specifications and Standard Test Procedures of RM, PM and FG , Analytical Method Validations and Analytical Method Transfers)
3) CQA Oversight:
• To ensure CQA oversight at SRC, Plant and CMO's.
• To monitor Initiation, execution and completion of activities as per SOP.
• Support customer and regulatory audits at plant, SRC and CMO's.
4) Internal Audits and Regulatory Compliance:
• To ensure the comprehensive internal audits (self-inspections) are being led by CQA at Head Office, Sentiss Research Centre and plant to identify the gaps and areas of improvement in order to not have any critical observations from audits by regulatory agencies, MoH, Customers, etc.
• To exhibit oversight on Contract Manufacturing Organization related activities through Quality Plans.
• Support in the internal audits/ compliance audits and regular surveillance at plant, Head officeand Sentiss Research Centre for ensuring compliance of Quality Systems.
5) Training:
• To provide training to all departments of SRC on GMP topics.
• Identify and assess training needs through appropriate inputs and processes; draw out overall external training curricula for CQA team.
6) Documentation Support:
• To ensure that correct and complete documents (Specification and STP) are provided timely to Quality Control section for analysis purpose.
• To ensure on time approval and closure of QMS documents (Change control, CAPA, Deviation,Recall, Mock recall, risk assessment, SOPs, vendor audit schedules, internal audits etc.) at Head office.
• Creation and implementation of Quality management system and procedures at the Research Centre and Corporate Office.
• Support in the investigation and closure of customer complaints related to products manufactured by Sentiss and CMO locations, investigation of Batch failures for the products manufactured by CML locations and OOS for stability studies.
• Support Plant QA and SRC for execution of Technology Transfer projects.
• Support review and release of batches manufactured at CMO locations.
7) Procedural requirement for Sentiss
• To ensure all system related procedure available for site / non site specific operations. Also ensure Policy / Philosophy documents available for guiding site and not site specific process covering material management.
8) Budgeting:
• To prepare the Opex and Capex budget for CQA, for routine working, resource requirement and for implementation of identified strategic actions.
9) Team Management:
• Conduct goal setting, performance appraisals and mentoring/coaching for own team members; collaborate with Head Corporate Quality Operations in manpower planning, recruitment activities and identifying training needs of team members for capability enhancement and maximize retention and performance.
Mandatory Skillsets:
• Experience of US FDA remediation
• Experience of handling/auditing CMOs, CDMO, CROs
• GMP & Regulatory Expertise (audit management)
• Aseptic Process and Sterility Assurance
• Quality Management System including Market complaints
• Risk Management & Environmental Monitoring
• R&D QA experience
COMPETENCIES:
• Leadership skills
• Decision-Making & Accountability
• Integrity & Compliance Orientation
• Communication & Influence
• Problem Solving & Analytical Thinking
• Adaptability & Resilience
• Team Work
• Continuous learning & Development
