Quality Assurance/Control - Pharma

Department: Quality assurance- External Supply Operations

Reports to (Job Title): Head Quality Assurance

Job Purpose:

- To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements.

Major Accountabilities:

- Responsible for driving / initiating External Supplier Quality Risk assessments for all External Suppliers. Gaps in Quality Systems are to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed.

- Provide leadership, direction and support to third parties (both local and global suppliers) and ensure that they are qualified, achieve a high level of competence and are motivated to carry out their duties in a safe manner.

- Lead new External Suppliers Qualification process.

- Ensure that a valid QA agreement is in place which is in line with the Global template clearly defining cGMP roles and responsibilities between the company and the External Supplier, as well as all product details and requirements. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.

- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the third parties.

- Ensure that all drug products are released in accordance with the registered specifications and are released to the market in accordance with local regulations and ensure that a respective Change Control procedure is in place.

- Responsible for coordinating and ensuring that Quality Auditing of External suppliers is carried out according to the Quality Manual - maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs.

- Audit, supervise and co-ordinate third party activities and ensure that third party manufacture, packaging, labelling and storage of products is in compliance with company's Standards.

- Ensure site readiness for regulatory inspections at External suppliers where appropriate.

- Manage all Critical Quality Issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Assurance Agreement and the Quality Manual. Ensure investigations are correctly executed. Ensure they are updated in AQWA (Adaptable Quality Workflow Application)

- Responsible for assessing Quality trends and driving Continuous improvement for processes and product quality performance.

- Ensure that the External Supplier provides Stability reports and PQRs as specified in the relevant Quality Assurance Agreement. Critically assess the performance of the product and process and provide the assessment to the report annually.

Education : Master In Pharmacy or Science

Languages: Hindi and English fluent in speaking / writing

Any other local languages

Experience:

- Min 8 years in Pharmaceutical industry experienced covering Quality Assurance, Quality Control and in that atleast 5 years of QA experience in a managerial role.

- Having some Production knowledge/ experience is desirable.

Please send me your CV on mkorudu@antal.com