Executive , Quality Systems Complaints
Advanz Pharma · Mumbai · onsite · Posted 44d ago
Undisclosed2–7 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Main purpose of role:
- Implementation of effective and compliant Quality systems specifically for Complaints and CAPAs.
- To assist in Recalls and Deviations when required.
Key responsibilities :
- Execute Complaints investigations in accordance with the defined procedures ensuring that:
- Complaints are raised in the system.
- Complaints are investigated to the required standard and that root cause is identified (leading to appropriate CAPA)
- Complaint s resolution is appropriately documented with supporting evidence.
- Liaising with CMOs and relevant stakeholders to ensure that complaints are investigated, resolved and closed in a timely manner.
- Interact with complaints reporter in the course of investigations and communicate the outcome of investigations accordingly.
- Follow up with CAPA owners to ensure that actions are implemented in a timely manner
- To assist in executing Recalls as required
- To assist in investigation of deviations when required
- Creation of Quality related documentation (SOPs, Risk Assessments etc.)
- Carry out internal audits as required
- Report Quality Systems metrics.
- Other activities as may be required, at the discretion of management.
Requirement
Essential
Desirable
Qualifications:
Minimum Honors Degree in Chemistry, Pharmacy or Microbiology
Sound working knowledge of all Microsoft Office applications
Experience Competences:
Minimum 2 years experience of working in a similar role within a pharmaceutical company.
Ability to use eQMS (eg. TrackWise, Veeva Vault etc.) for Quality Systems management
Capable of working to deadlines remain calm under pressure
Proven ability to organize and prioritize tasks
Ability to work on own initiative
Ability to work effectively as part of a team
Knowledge Skills:
Excellent communication skills, both oral and written, to include senior management where escalation is required.
Well organised with logical methodical approach to work
Sound problem solving skills
Knowledge of ICH Q9, ICH Q10 and Eudralex- Volume 4 Good manufacturing practice (GMP) guidelines
Personal Qualities:
Professional, methodical approach to work with can-do attitude
Even tempered, positive personality, approachable with team spirit
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
HashiCorp Vaultcmostrackwisemicrosoft officeauditsChemistryVeeva vaultCAPAPharmacyQuality SystemsMicrobiologyCommunication SkillsManufacturingPharmaceutical
About Advanz Pharma
Advanz Pharma
Pharma
201
employees
1963
63 years old
Mumbai, Maharashtra
India
₹14.7L PA avg
Avg at Advanz Pharma
About
Advanz Pharma is a global pharmaceutical company focused on commercializing specialty and rare disease medicines, partnering with innovative firms to enhance patient care.
Industries
PharmaHealthcare / Pharma
Employee ratings
10 reviews
4.2/ 5
Culture
4.8
Career growth
2.8
Work-life
4.4
Employees rate it well for
Company Culture45Work-Life Balance44
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