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Friday, October 8, 2010

GM-QA/QC Scott-Edil Pharmacia Ltd.

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

 
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.
Executive Name:
Amarjeet Singh / Alok Anand
Address:
Scott-Edil Pharmacia Ltd
Phase-II,
Chandigarh
CHANDIGARH,Chandigarh,India 160002
Telephone:
9805048855-9996293777

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