Job Description
(Requirement is for Domestic Market only)
JOB PURPOSE:
Management of site regulatory compliance, internal and external audits, centralized document control (BMR, BPR, SOPs, Logbooks etc.), Print Pack Instructions / Artworks, Technical Terms of Supply and regulatory related investigations at site.
KEY RESPONSIBILITIES:
• Ensure site inspection readiness at all time.
• Ensure zero regulatory sanction. Show Cause Notice(s), warning letter(s) are responded on priority in discussion with Site Quality Head.
• Effective management of FDA inspections to avoid any critical remark(s) in the inspection book.
• Ensure regulatory submissions are done in timely manner. Maintain cordial relations with regulators.
• Ensure timely support is extended for tender business.
• Management of Technical Terms of Supply to ensure they are current & updated timely.
• Contractual agreements are in place & updated on time.
• Ensure Print Pack Instructions / artworks at site are in compliance with regulatory requirements & revised in timely manner.
• Ensure effective management of regulatory documents and BMRs for easy retrieval and retention.
• Ensure 100% adherence to training plan for the self & the team.
• Ensure effective Quality Management System implementation in the area of responsibility.
• Ensure internal audit processes at site are in compliance with regulatory and Quality Management System requirements.
• Ensure timely reporting & effectiveness of the Key Performance Indicators.
• Ensure all the SOPs in the area under control are updated timely and in current state.
• Timely escalation of the issues through departmental performance review meetings / Site Leadership Team meetings & Site Quality Councils.
• Identification & closure of the risks as per the risk mitigation plan in the areas of responsibility.
• Management of local and above site investigation committee meetings.
• Ensure no overdue change controls, deviations, CAPAs in the area of responsibility.
• Annual review and report preparation of the systems under control
(Requirement is for Domestic Market only)
JOB PURPOSE:
Management of site regulatory compliance, internal and external audits, centralized document control (BMR, BPR, SOPs, Logbooks etc.), Print Pack Instructions / Artworks, Technical Terms of Supply and regulatory related investigations at site.
KEY RESPONSIBILITIES:
• Ensure site inspection readiness at all time.
• Ensure zero regulatory sanction. Show Cause Notice(s), warning letter(s) are responded on priority in discussion with Site Quality Head.
• Effective management of FDA inspections to avoid any critical remark(s) in the inspection book.
• Ensure regulatory submissions are done in timely manner. Maintain cordial relations with regulators.
• Ensure timely support is extended for tender business.
• Management of Technical Terms of Supply to ensure they are current & updated timely.
• Contractual agreements are in place & updated on time.
• Ensure Print Pack Instructions / artworks at site are in compliance with regulatory requirements & revised in timely manner.
• Ensure effective management of regulatory documents and BMRs for easy retrieval and retention.
• Ensure 100% adherence to training plan for the self & the team.
• Ensure effective Quality Management System implementation in the area of responsibility.
• Ensure internal audit processes at site are in compliance with regulatory and Quality Management System requirements.
• Ensure timely reporting & effectiveness of the Key Performance Indicators.
• Ensure all the SOPs in the area under control are updated timely and in current state.
• Timely escalation of the issues through departmental performance review meetings / Site Leadership Team meetings & Site Quality Councils.
• Identification & closure of the risks as per the risk mitigation plan in the areas of responsibility.
• Management of local and above site investigation committee meetings.
• Ensure no overdue change controls, deviations, CAPAs in the area of responsibility.
• Annual review and report preparation of the systems under control
Candidate Profile
Candidate must possess at least a Bachelor of Science, Bachelor of Pharmacy, Master of Science, Master in Business Admin/Post Graduate Diploma in Business Administration/Post Graduate Program in Management or Master of Pharmacy in Pharmacy/Pharmacology or equivalent.
At least 12 year(s) of working experience in the related field is required for this position.
Preferably Managers specializing in Quality Control/Assurance or equivalent. Job role in Quality Control/Assurance or equivalent.
1 Full-Time position(s) available.
Candidate must possess at least a Bachelor of Science, Bachelor of Pharmacy, Master of Science, Master in Business Admin/Post Graduate Diploma in Business Administration/Post Graduate Program in Management or Master of Pharmacy in Pharmacy/Pharmacology or equivalent.
At least 12 year(s) of working experience in the related field is required for this position.
Preferably Managers specializing in Quality Control/Assurance or equivalent. Job role in Quality Control/Assurance or equivalent.
1 Full-Time position(s) available.
Additional Information:
Experience: Min. 12 years
Location: Nashik
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 15th June, 2014
Experience: Min. 12 years
Location: Nashik
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 15th June, 2014
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