Job Role Summary : Lead inspection process in the plant, Internal audit/ Self Inspection, CAPA Management, Supplier Quality Management
Job Profile
- Lead inspection process in the plant
- Coordinate with external parties/ internal CFT/ Quality Head and Site Head to organize regulatory inspections/ customer/ certification body audits at site.
- Will be responsible to update Senior Management on the audit process and outcome on a timely basis as per SOP
- Will be responsible for timely response to the observations generated from the inspection, initiation of CAPAs in order to address the observations, follow-up with the responsible person/ department for completion of the actions within due date, review of CAPA/ action item closure for adequacy and involve in effectiveness check
- Frequent shop-floor visit in order to verify the compliance status, identifying and highlighting possibilities of repeat observation and potential noncompliance that can lead to observation during inspections
- 483 observations/ other inspectional observations- perform gap assessment and implement CAPA in case of any gaps.
- Lead Internal audit/ Self Inspection
- Ensure effective self-inspection process is in place to proactively detect potential compliance risk and mitigate through effective CAPA.
- Plan,
coordinate and ensure compliance.
- Driving system and facility improvements based on the gaps identified during self-inspection.
- Supplier Management
- Responsible for qualification of suppliers related to API/RM/PM
- Responsible for qualification of suppliers for critical consumables and items used in aseptic areas.
- Responsible for qualification of other service providors
- Coordinate for risk assessments in case of any noncompliance observed with respect to suppliers
- Global Actions/ CAPAs
- Coordinate with Global Quality Management with respect to assessment and remediation of the gaps identified in other facilities of Sun or other organizations.
- Others:
- Training of team members in order to enable them to perform their jobs in proper way.
Job Requirements
- Ovearall experience of atleast 15 to 16 Yrs and >3 years of experience as Compliance Lead/ QMS Lead
Work / Job Experience : 14-15 Years Type of Experience : Experience as Quality, QMS, Compliance Lead
Academic Qualifications
B.Pharm / M.Pharm / MSc
Job Post Link : https://tinyurl.com/ydyu979b
- Full Time
- India | Gujarat | Baska
- Posted 50 mins ago
Website Linkedin Sun Pharmaceutical Industries Ltd To apply for this job please visit careers.sunpharma.com.