review and update standard operating procedures (sops) to align with changing regulations and best practices. documentation and records management
- maintain and manage documentation related to quality assurance activities, including batch records, investigation reports, change controls, and validation documentation.
- ensure accurate and timely completion of all quality-related documentation. product quality control
- investigate product non-conformances, deviations, and customer complaints to identify root causes and implement appropriate corrective and preventive actions (capas).
- knowledge of good manufacturing practices (gmp), good laboratory practices (glp), and other relevant quality standards.
- making decisions on batch disposition and product recall based on root cause identification.
- reviewing and approving compliance reports following external (customer/regulatory) audits and corporate audits to ensure compliance.
- preparing and implementing quality assurance policies and procedures and ensure that standards and safety regulations are observed.
- timely completion of apqr related activity
- prepared & review of validation protocol and report (like process validation, cleaning validation, analytical method validation,)
- handling of market complaint and related compliance
- handling of out of specification and suitable investigation
- handling of deviation and incident
- prepared bmr, sop, protocols etc.
- compliance of vendor audit, regulatory audit etc.
skills & qualification
education:
ug: / m
pg: / m. pharm
knowledge of computer competence, including database management
minimum experience required: 1 - 3 year
cv required
Experience
1 - 6 Years
No. of Openings
02
Education
B.Pharma, B.Sc, M.Pharma, M.Sc
Role
Quality Assurance Executive
Industry Type
Manufacturing / Production / Quality
Gender
[ Male / Female ]
Job Country
India
Type of Job
Full Time
Work Location Type
Work from Office