Accutest - Head - Quality Assurance

Location : Navi Mumbai (Kopar khairne)

Job Responsibility :

- Report to management on time to time basis about the audit findings & corrective actions for the non-compliance

- To review and approve SOP and all pertinent documents required by the regulations

- To supervise the calibration and maintenance schedule as per in house frequency

- To supervise day to day workflow and necessary distribution to meet the time line

- To supervise the vendor audit compliance

- To supervise the basic training to the staff from GXP point of view.(GXP i.e. GCP,GLP,GDP etc)

- To plan and supervise internal audits of the various departments like QA, BAL, Clinical, Statistic, IT, etc.

- To plan and supervise study based audits of the BA/ BE studies that includes Clinical, Analytical and Statistical documents

- To plan and supervise process based audits

- To plan and supervise system based audits

- To review and update the information for guidelines, regulatory requirements and make the necessary amendments in the systems as and when required

- Escort the visitor and external auditor for the site approval

- Conduct frequent visit to facility for the compliance of in house SOPs and Regulatory requirements

- Effectively evaluate QA staff for required training updation and work distribution

- To solve and respond the regulatory and sponsor query

- To supervise the documentation procedure followed by quality assurance department

- To supervise the archiving procedure and overall compliance of all departments

- To attend/host the Regulatory Inspectors opening meeting and act as an auditee as per the requirement of Regulatory Inspector during Inspection round and review of the data.

Required Education and Experience :

- Ph.D. / M. Pharm / M.Sc. with 10-15 years (preferable 12+ years) of relevant industry experience

- Proven track record in senior position of QA management with similar responsibilities

- Ability to travel

- Excellent verbal and written communication skills.