Partnering with the right recruitment specialist can add value to your business and simply make your life easier. Our mission is to be a world leader in matching demand for and supply of talent and HR services. With 55 years of global HR heritage and 23 years of being HR pioneers in India, Randstad provides clients immediate access to immense global and local HR expertise to drive business performance. Randstad is India's market leading HR services provider offering the broadest portfolio ranging from permanent recruitment and contract staffing to recruitment process outsourcing.
Post: Manager - QA in Hyderabad
Job description
- Responding to Customer Complaints through comprehensive investigation.
- Assurance to Returned Goods and Recalls and investigation on actual impacts.
- Investigation and Resolving of Unplanned Deviations / Incidents.
- Implementation of Planned Deviations with sound justifications.
- Co-Ordination in Internal, External Audits & Preparation of Compliance Reports to Regulatory & Customer Audit reports & Effective monitoring on CAPA implementation before the targeted dates committed in Compliance Reports.
- Conducting meticulous study on Quality Risk Management System at various locations.
- Designing & conducting all types of Validations & Approval of Validation Protocols & Reports.
- Review & Approval of Annual Review Reports of all Drug Substances and Water.
- Setting up and maintaining controls and documentation procedures in Online.
- Preparation/Modification of Standard Operating Procedures as convenient unless exceeding the cGMP requirements.
- Review & Approval of Batch Production Records, master Formulae, Standard Testing Procedures & Stability Trends.
- Imparting Trainings to all employees in various aspects like cGMP, SOPs & Job Oriented.
- Approved Chemist and Releasing the products into International & Domestic markets.
- Execution of Temporary & Permanent Changes through Change Control system & providing updates to Regulatory Agencies on Summary of Changes.
- Review and Approval of Qualifications of Equipments.
- Co-ordination in Qualification of Clean Rooms and its establishments.
- New and existing Vendors Evaluation & Scheduling, performing the Vendor Audits.
- Review & Implementation of Technology transfer/Development reports.
- Co-ordination on Product Site transfer.
- Controlling of recovery solvents consumption.
- Implementation of periodical cleanings and Holding time studies.
- Evaluation & Approval of Site master File & Validation Master Plan.
- Modifying the existing standards as in-line with respective Pharmacopoeia/Customer Specific as and when they updated.
- Implementation of reprocess procedures.
- Acquiring the Product Licenses by interacting with concerned departments.
- Frequent Plant monitoring to complying cGMP aspects.
- Scheduling the Management Review Meeting, Execution of Outcomes.
- Developing the Cost reductions at various locations.
- Working with purchase staff to establish quality requirements
- Implementation of Reduced Testing based on the Product Quality History.
- Allotting the Job responsibilities & work profiles to the QA personnel.
- Updating cGMP Practice based on Updated Guide lines.
- Proper planning on Document control/Achieving.
Benefits
Salary and Career growth
Brand and reputation
Client Introduction
Leading contract research and testing organization. Established in 1984 and has an envious track record of serving several market leaders across the globe.
It is a team of 783 professionals comprising 458 scientists in various disciplines such as Chemistry, Pharma, Medicine, Microbiology, Molecular biology and Informatics. The team is slated to double in next three years.
Qualification
- Responding to Customer Complaints through comprehensive investigation.
- Assurance to Returned Goods and Recalls and investigation on actual impacts.
- Investigation and Resolving of Unplanned Deviations / Incidents.
- Implementation of Planned Deviations with sound justifications.
- Co-Ordination in Internal, External Audits & Preparation of Compliance Reports to Regulatory & Customer Audit reports & Effective monitoring on CAPA implementation before the targeted dates committed in Compliance Reports.
- Conducting meticulous study on Quality Risk Management System at various locations.
- Designing & conducting all types of Validations & Approval of Validation Protocols & Reports.
- Review & Approval of Annual Review Reports of all Drug Substances and Water.
- Setting up and maintaining controls and documentation procedures in Online.
- Preparation/Modification of Standard Operating Procedures as convenient unless exceeding the cGMP requirements.
- Review & Approval of Batch Production Records, master Formulae, Standard Testing Procedures & Stability Trends.
- Imparting Trainings to all employees in various aspects like cGMP, SOPs & Job Oriented.
- Approved Chemist and Releasing the products into International & Domestic markets.
- Execution of Temporary & Permanent Changes through Change Control system & providing updates to Regulatory Agencies on Summary of Changes.
- Review and Approval of Qualifications of Equipments.
- Co-ordination in Qualification of Clean Rooms and its establishments.
- New and existing Vendors Evaluation & Scheduling, performing the Vendor Audits.
- Review & Implementation of Technology transfer/Development reports.
- Co-ordination on Product Site transfer.
- Controlling of recovery solvents consumption.
- Implementation of periodical cleanings and Holding time studies.
- Evaluation & Approval of Site master File & Validation Master Plan.
- Modifying the existing standards as in-line with respective Pharmacopoeia/Customer Specific as and when they updated.
- Implementation of reprocess procedures.
- Acquiring the Product Licenses by interacting with concerned departments.
- Frequent Plant monitoring to complying cGMP aspects.
- Scheduling the Management Review Meeting, Execution of Outcomes.
- Developing the Cost reductions at various locations.
- Working with purchase staff to establish quality requirements
- Implementation of Reduced Testing based on the Product Quality History.
- Allotting the Job responsibilities & work profiles to the QA personnel.
- Updating cGMP Practice based on Updated Guide lines.
- Proper planning on Document control/Achieving.
Additional Information:
Location: Hyderabad, Andhra pradesh
Reference number: 908993
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Manufacturing
End Date: 31st August, 2015
See All Novartis Jobs B.Pharm Alerts M.Pharm Alerts M.Sc Alerts
See All Other Jobs in our Database
.png)
