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Sunday, October 3, 2010

General Manager QA 2 Opening(s)

Summary

Experience:
14 - 24 Years
Location:
Baddi, Indore
Compensation:
Negotiable on Current CTC
Education:
UG - B.Pharma - PharmacyPG - M.Pharma,M.Sc - Chemistry
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Regulatory Affairs Mgr
Functional Area:
Healthcare, Medical, R&D

Desired Candidate Profile

Behavioral Competencies:

• Strong interpersonal and communication skills.

• Ability to work cross-functionally.

• Proven people and project management skills.

• Ability to influence others and lead teams.

• Demonstrates core values.

 

Job Description

Quality Operations :

• Regulatory Compliance: Ensure the compliance at the site as per GMP and regulatory requirement.

• Establish and maintain globally harmonized key quality systems and standards and facilitate their consistent implementation across site.

• Internal and Vendor Audit Management: Planning, development, and execution of an internal audit and vendor audit program, including follow-up and facilitation of corrective actions.

• Handling of market complaints: Investigating to identify the root-cause and identifying Corrective Action and Preventive Action (CAPA) to avoid recurrence of complaint and occurrence of potential complaint and thereby responding to complainant satisfactorily.

• Deviation Management: Investigate to identify the root-cause for deviation from system and identifying CAPA to avoid recurrence of deviation and occurrence of potential deviation.

• Review and approve process validation / equipments Qualification documents.

• Change Control Management- Review proposed changes with respect to impact on product quality and taking appropriate decision (approve/ reject). Implementation of proposed change and closure.

• Preparation of online Annual Product Review (APR) for each product.

• Define a documentation hierarchy starting top-down, taking into account the following :

o Overall Ranbaxy quality philosophy and expectations.

o Requirements and expectations of quality systems that need to be adhered to globally.

o Harmonize procedures for selected key Quality Systems that describe detailed workflows and are to be followed globally for day-to-day operations (Global Quality Standards).

• Maintain a network of subject matter experts in critical operating areas, including environmental monitoring, microbiology, containment programs, and facilities/ utilities/ qualifications & validations, and QC systems.

Technical Competencies:


• Understanding of pharmaceutical manufacturing, packaging, quality assurance, quality control, and reg. affairs operations.

• Knowledge of validation principles and practices related to one or more of the following areas: manufacturing process, analytical method, facility, equipment, instrument, utility system, and/or IT systems.

• Experience in relevant technical drug product platforms (API, solid dosage, steriles, liquid orals, topicals, etc.).

• Experience in application of GMP to QA/QC operations.

• Knowledge of QC/QA processes, relevant countries’ regulatory requirements and internal QS policies and procedures.

• Ability and experience in handling regulatory agency inspections at site.

• Thorough knowledge and sound understanding of cGMP concepts defined by US-FDA, MCA-UK, TGA-Australia, MCC-South Africa, ANVISA/ WHO etc.

Keywords: GM QA,DGM QA,formulation,AGM QA,Head QA,Sr manager QA, Quality Compliance,Regulatory compliance,QA & RA,QMS,Quality management system,CAPA

Company Profile

Leading multi locational Pharma companies having its formulation units all over India.
Contact Details
Company Name:
Reputed Pharmaceutical Company
Website:
Not Mentioned
Executive Name:
Anil ummatt
Address:
SCO 81,2nd Floor Swastik Vihar,MDC.Sector 5
Panchkula
CHANDIGARH,Chandigarh,India 160001
Telephone:
91-172-4667860

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