Looking for Head Quality Assurance

By: Pharma Jobs | Views: 3346 | Date: 20-Nov-2012

Posted By - HR Axis India Pvt Ltd.. Keywords - Quality Assurance, QA, q.a.. Job Description - Position Title : Head of Quality Assurance Department Location :Hyderabad Academic Background and Experience : Ideally, the candidate should be a B.E/ B.Tech (Chemical Engg.) About 10-18 Years of experience Knowledge of pharmaceutical Industry is only preferable. Job responsibilities: Responsible for maintaining and ensuring compliance to the Quality System.  Audit and ap

Looking for Head Quality Assurance




QA -02




Job Description
Position Title : Head of Quality Assurance Department

Location :Hyderabad

Academic Background and Experience :

Ideally, the candidate should be a B.E/ B.Tech (Chemical Engg.)
About 10-18 Years of experience
Knowledge of pharmaceutical Industry is only preferable.

Job responsibilities:
  • Responsible for maintaining and ensuring compliance to the Quality System. 
  • Audit and approval of contract manufacturing facilities, supplier qualification activities and Managing Internal Audits
  • Leading and guiding a team of QA professionals
  • Technology transfers, validations and DMF filing for development APIs.
  • Handling Technology transfers, manufacturing and release of drugs for clinical/pre-clinical trials.
  • Handling Regulatory/customer audits and compliance.
  • Batch release of APIs and intermediates.
  • Approval of SOPs, Spec and TMD for Raw materials, Finished Products and In Process tests.
  • Handling and investigation of OOS test results, deviations, customer complaints, return goods and implementing CAPA.
  • Control and approval of changes in Process, procedures and compliance to DMF requirements.
  • Validation master plans and execution.
  • Preparation of Annual Product Review reports.
  • Support for new DMF filings and response to deficiencies.
  • Support to customer queries through marketing. 
  • Monitoring stability study.
  • Equipment qualifications, validation of utility systems, DI water/Purified water systems and HVAC. Handled commissioning and qualification of new projects.
  • Training of Employees on Standard Operating Procedures and cGMP.

Areas of Expertise and Exposure:

  • Validation master plans: Process Validation, Cleaning Validation, Analytical Method Validation, Equipment Qualification, Validation of DI/Purified water system and HVAC systems. 
  • Review of Quality Agreements.
  • Audit and Compliance, supplier qualification activities.
  • Exposure to a high level of GMP compliance in a corporate culture.

If you are looking for job change then please send your updated CV along with below mentioned details on
profile2@hraxisindia.com


1. Present CTC:
2. Expected CTC:
3. Notice Period:


Thanks & Regards

Bharathi

HR Executive

HR Axis India Pvt. Ltd.
102, 1st floor, My Home Laxmi Nivas,
Opp Hotel Green Park,
Ameerpet,

Hyderabad 500016

Tel No. 040-66410378,

email: profile2@hraxisindia.com

Url: www.hraxisindia.com

"We do not take any charges from the candidate"
Salary:

Not Disclosed by Recruiter

Industry:

Pharma, Biotechnology, Clinical Research

Functional Area:

Production, Manufacturing, Maintenance

Role Category:

Production/ Manufacturing/ Maintenance

Role:

Quality Assurance/ Quality Control Manager

Keyskills:

Quality Assurance, QA, q.a.

Desired Candidate Profile
Education:

(UG - B.Tech/B.E. - Chemical) OR (PG - Post Graduation Not Required, Any PG Course - Any Specialization) AND ( Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required)

Please refer to the Job description above
Company Profile
HR Axis India Pvt Ltd.
Hexa Resource Axis India Private Ltd (HR Axis India) is a Human Resource Management Consultancy organisation providing specialised HR services to clients in India across different sectors.
Contact Details
Recruiter Name:

Bharathi.L

Email Address:

profile2@hraxisindia.com

Telephone:

040-66410378

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