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
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.