Requirement of Quality Head for Virchow Biotech- Hyderabad

Developing and implementing the Quality department’s strategy, to ensure it meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals.

Implementing and monitoring all Quality Assurance systems to ensure compliance with relevant regulatory directions, covering GMP for medicinal products for human use and investigational medicinal products (IMPs) for human use.

?Implementing and maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements (Regulatory Guidelines)

?Acting as the main point of contact on all Quality matters, internally and externally.

Coordinating MHRA inspections, Home Office inspections, Pharmacy inspections and internal inspections.

?Maintaining MHRA authorisations, including submission of variations (named on licences as responsible for Quality Control)

Ensuring regulatory compliance with Domestic Office licence.

Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost

Ensuring the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially.

Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies.

Ensuring that there is an audit programme in place which is communicated to Operations.

Ensuring that the supplier and subcontractor audits are performed and reported as scheduled.

Ensuring that there is a self-inspection programme in place which is communicated to Operations to meet the requirements of EU GMP

Managing all validation activities, including validation strategy and approval of protocols and reports

Maintaining an awareness of new and proposed legislation that impacts the business and communicating any changes to the Senior Management Team (SMT).

Ensuring the availability of adequate competent resources to carry out the review and approval batch documentation in accordance with in house and GMP requirements

Ensuring sufficient QP resource to provide QP certification for commercial and clinical trial products

Preparing, reviewing and approving Technical and Quality Agreements

Ensuring appropriate investigation of discrepancies, errors, complaints, failures or adverse events requiring documented review and action (if necessary, interrupting processes causing material to be quarantined or placed on hold until matters are resolved).

Leading customer and regulatory audits/inspections, as required

Qualification : Any P.G (P.hD would be additional credential)

Experience : 20 to 25 years

budget : 35lpa to 45lpa

Regards,

Raghurami Reddy Palugulla,

Sr Manager HR.

Virchow Biotech Pvt Ltd

Hyderabad.

Mob-9642996045.