Summary
Experience:
12 - 15 Years
Location:
BADDI HP
Compensation:
Best in the industry...
Education:
UG - B.Pharma - PharmacyPG - M.Pharma - Pharmacy
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
QA&QC Mgr
Functional Area:
Engineering Design, R&D
Desired Candidate Profile
Candidate should be B-Pharm with 12-15 years of experience in Pharma Formulation Unit.
Job Description
Quality Assurance activities, Builds & executes Quality Assurance strategies, Quality Assurance plan, international compliance,
Verify contractor quality requirements are specified to vendors and contractor documentation submittals.
The preparation of the companies QA manual control and supervision of all amendments and revisions
Control and the distribution of all the companies quality documentation
Perform all internal and external audits on behalf of the companies management
Attend client quality management meetings
Review quality inspection personnel qualifications and training requirements
Monitor the disposition of all issued nonconformance reports.
Coordinate all QA/QC activities with the site QC manager
Coordinate all QA/QC activities with the site QA/QC procurement manager
Coordinate all quality related correspondence with the customers representatives.
Monitor statistical method reporting.
Action and close all customer complaints
Control all achieve documentation upon the completion of the project
The control of onsite and offsite vendor inspectors
The compilation of vendor inspection assignments packages
The coordination and resolution of any nonconforming product Reviewing vendors QA/QC systems in accordance with contractual requirements
Coordination of vendor quality approvals when required
Ensure the verification of documentation and certificates for materials purchased by vendors
Review procurement documents to ensure that quality requirement have been correctly translated into purchase requisitions and design documents
Review supplier inspection procedures and personnel qualifications
Review supplier material certificates
Take part in supplier audit and surveillances
Coordinate with the companies discipline engineers for the resolution of technical discrepancies
Coordinate with management for quality improvements
Issue of nonconformance reports
Track all nonconformance reports
Coordinate with the owner’s representative
Implement the QA/QC management system at site
Coordinate with quality inspections with all the site sub contractors and vendors coordinate all non destructive testing on site
Coordinate with the customer’s representative on all quality matters
Coordinate all receipt inspections
Verify that the quality related site activities are in accordance with the applicable codes and standards
Participate in the site internal and external site audits
Coordinate all the quality site inspections through the site QC inspectors
Ensure all quality control documentation is complied and competed for as-built hand over through the
Control all nonconformance reports and undertake remedial action
Compete site quality control instructions and action remedial responses
Review the customers specification and undertake relevant training to the site QC inspector
Monitor the implementation of the approved site QC Plan
Complete and coordinate the approval of the sites QC technical submittals to the customer
Elaborating inspection and test programs
Ensure the integrity and legal compliance of the product by engaging, and working with, Client Representative, Client and project personnel..
Provide advice and guidance to the project delivery team on all matters of verification and regulatory compliance
Co-ordinate the implementation of certification assurance processes within the project for regulatory compliance
Verify contractor quality requirements are specified to vendors and contractor documentation submittals.
The preparation of the companies QA manual control and supervision of all amendments and revisions
Control and the distribution of all the companies quality documentation
Perform all internal and external audits on behalf of the companies management
Attend client quality management meetings
Review quality inspection personnel qualifications and training requirements
Monitor the disposition of all issued nonconformance reports.
Coordinate all QA/QC activities with the site QC manager
Coordinate all QA/QC activities with the site QA/QC procurement manager
Coordinate all quality related correspondence with the customers representatives.
Monitor statistical method reporting.
Action and close all customer complaints
Control all achieve documentation upon the completion of the project
The control of onsite and offsite vendor inspectors
The compilation of vendor inspection assignments packages
The coordination and resolution of any nonconforming product Reviewing vendors QA/QC systems in accordance with contractual requirements
Coordination of vendor quality approvals when required
Ensure the verification of documentation and certificates for materials purchased by vendors
Review procurement documents to ensure that quality requirement have been correctly translated into purchase requisitions and design documents
Review supplier inspection procedures and personnel qualifications
Review supplier material certificates
Take part in supplier audit and surveillances
Coordinate with the companies discipline engineers for the resolution of technical discrepancies
Coordinate with management for quality improvements
Issue of nonconformance reports
Track all nonconformance reports
Coordinate with the owner’s representative
Implement the QA/QC management system at site
Coordinate with quality inspections with all the site sub contractors and vendors coordinate all non destructive testing on site
Coordinate with the customer’s representative on all quality matters
Coordinate all receipt inspections
Verify that the quality related site activities are in accordance with the applicable codes and standards
Participate in the site internal and external site audits
Coordinate all the quality site inspections through the site QC inspectors
Ensure all quality control documentation is complied and competed for as-built hand over through the
Control all nonconformance reports and undertake remedial action
Compete site quality control instructions and action remedial responses
Review the customers specification and undertake relevant training to the site QC inspector
Monitor the implementation of the approved site QC Plan
Complete and coordinate the approval of the sites QC technical submittals to the customer
Elaborating inspection and test programs
Ensure the integrity and legal compliance of the product by engaging, and working with, Client Representative, Client and project personnel..
Provide advice and guidance to the project delivery team on all matters of verification and regulatory compliance
Co-ordinate the implementation of certification assurance processes within the project for regulatory compliance
Keywords: QA, QC, GM,General manager, pharma, Biotech, formulations, M.pharma, Baddi, QC inspector.
Company Profile
M/s Scott-Edil Advance Research Laboratories & Education Ltd. is a Pharmaceutical manufacturing unit , located at Hill Top Industrial Area, Bhatoli kalan Baddi, Distt : Solan (H.P.) India, which is approx. 45 kms. away from Chandigarh. It is located on an open plot area appox. 68000 square meter, & built up area is approx. 12000 square meter. The factory under establishment in year 2010 & is situated in a serene atmosphere free from vehicular and any adverse environmental pollution.Scott-Edil Advance Research Laboratories & Education Ltd has separate production Block which is categorically utilised for production of Following Dry Powder Injectable, Tablet,Capsule and Dry syrup Formulations:
1. Block DPI (Dry Powder Injection)
2. Block OSD (Tablet, Capsule & Dry syrup)
Contact Details
Company Name:
Scott-Edil Pharmacia Ltd.
Website:
Executive Name:
Amarjeet Singh / Alok Anand
Address:
Scott-Edil Pharmacia Ltd
Phase-II,
Chandigarh
CHANDIGARH,Chandigarh,India 160002
Phase-II,
Chandigarh
CHANDIGARH,Chandigarh,India 160002
Email Address:
Telephone:
9805048855-9996293777
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