Cal Scientific
Website:
calscientific.com
Job details:
Qualification
M.Sc. / M. Pharma
Experience
Minimum 12-15 years
Job Location - Mulund, Mumbai.
Role Overview
Responsible for leading qualification and calibration activities for defined analytical instruments and equipment in accordance with approved schedules, procedures and QMS requirements. Responsible for QMS activities including SOPs, Change Controls, CAPA, Deviations, Investigations and effectiveness checks.
Illustrative Responsibilities
Lead and manage quality compliance activities for laboratory instrument qualification and calibration.
Coordinate with laboratory supervisors, system owners, QA, and other stakeholders for non-conformances, technical issues and escalations.
Ensure qualification, calibration, requalification and periodic activities are completed within approved schedules and applicable requirements.
Review, summarize and report analytical instrument qualification and calibration activities for appropriate review and approval.
Review qualification/calibration protocols, reports and supporting documentation for accuracy, completeness, traceability and compliance.
Monitor overdue, failed or out-of-tolerance instruments and ensure timely escalation, investigation and appropriate disposition.
Lead investigations related to instrument failures, calibration failures, deviations and non-conformances, including root-cause analysis and CAPA.
Ensure timely implementation and effectiveness checks of CAPA and other corrective/preventive actions with proper documentation.
Coordinate with client laboratory teams and act as a technical and quality point of contact for assigned activities and escalations.
Ensure Good Documentation Practices (GDP), data integrity and Right First Time (RFT) principles are consistently followed in the technical function.
Lead and strategize analytical and technical improvement initiatives, including reduction of recurring instrument and compliance issues.
Develop and monitor qualification/calibration schedules, resource requirements, turnaround time and completion status.
Provide technical guidance, coaching and support to team members and ensure appropriate competency and training.
Promote a disciplined, collaborative and professional work environment and build a cohesive team.
Prepare and provide periodic status reports, KPI updates and management escalations relating to quality, compliance and service performance.
Support internal, client and regulatory audits by ensuring documentation, records and technical evidence are complete and inspection ready.
Ensure team compliance with EHS, Quality and Business policies and all applicable client/site procedures.
Perform any other quality, technical or management responsibilities assigned by CalScientific management from time to time.
Quality & Compliance
Responsible for following and ensuring team compliance with applicable GMP, GLP, GDP, EHS, data integrity and client quality requirements. Knowledge of NABL (17025-2025) is a plus
Ensure QMS activities, technical records and documentation are maintained in accordance with approved procedures and applicable regulatory expectations.
Support audit and inspection readiness and timely closure of observations, deviations and CAPA.
Required skills
Strong technical expertise in analytical instrument qualification, calibration, requalification, protocol preparation and QMS.
Strong knowledge of analytical laboratory instruments, qualification requirements, calibration parameters and acceptance criteria.
Ability to review and approve, as applicable, qualification/calibration protocols, reports and technical documentation.
Strong experience in CAPA, investigations, deviations, change controls, non-conformances and root-cause analysis.
Ability to identify quality and technical risks, anticipate implications and take appropriate action without compromising quality.
Ability to manage multiple priorities, schedules, resources and client requirements while maintaining quality and compliance.
Strong client-facing, stakeholder-management and escalation-management skills.
Ability to build and lead a cohesive team, develop people and promote teamwork and accountability.
Clear, concise and effective written and verbal communication skills.
Strong problem-solving, decision-making and analytical skills with a Right First Time mindset.
Job requirement
M.Sc. specializing in Chemistry or related discipline / M. Pharma with a minimum of 12-15 years of relevant experience in pharmaceutical, biotechnology, life-sciences or analytical laboratory environments.
Proven experience in analytical instrument qualification, calibration, requalification and validation-related activities.
In-depth experience in Chromatography (HPLC, UPLC, GC and preferably GC-MS/LC-MS), Spectroscopy (MS, FTIR, UV), Particle Size Analyzers, Dissolution Testers, balances, pH/conductivity meters and other laboratory analytical instruments.
Expertise in analytical instrument qualification and calibration, protocol and report preparation/review, CAPA, investigations, deviations, change controls and other QMS activities.
Good knowledge of GMP, GLP, GDP, data integrity principles, ICH guidelines and applicable requirements of global regulatory authorities.
Experience working with multinational pharmaceutical/biotechnology companies will be an advantage.
Strong leadership, team-management, technical communication and client-management capabilities.
Share CV on ruchita.p@calscientific.com
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