Lead - Development Quality Assurance (DQA)
4 weeks ago
Location: Hyderabad
Purpose:
Responsible and accountable for implementation, monitoring and continues improvement of quality system, corporate guide lines and new initiatives at APSL.
Desired Profile
- M.Sc. /M. Pharm/Chemical Engineer/Ph. D with 14-17 years' experience
- Preferably candidate should have experience in Analytical development, Development Quality Assurance or API Quality Assurance
Responsibilities:
- Responsible and accountable for review, approval and implementation of Standard operating procedures/ Guidelines/Policies and change control Documents.
- Responsible and accountable to keep laboratory in all time compliance and inspection ready.
- Accountable in order to facilitate effective Incident investigations in a timely manner and implementation of CAPA for all APSL projects and general incidents within APSL.
- Negotiation, approval and monitoring of customer quality agreements and ensure its compliance.
- Participate and facilitate in qualification of new strategic Business partners (SBP) by following established procedures, this would further include to audit and approve quality agreement with the SBPs.
- All time readiness to engage with customer interaction and respond to their queries with appropriate details.
- Facilitate the quality team to achieve successful technology transfer of new products to manufacturing plants and supporting Regulatory Affairs team for DMF filing and regulatory deficiency response.
- Verification of gate clearance documents of the HPT and guiding / supporting other DQA members for technical evaluation of their gate clearance documents
- Support respective plants during the regulatory audits and customer audits for products which are developed and transferred from APSL in order to ensure and provide sufficient details w.r.t development aspects of the product.
- Facilitate and support Internal manufacturing plants and SBPs for customer complaints investigations and closure.
- To perform internal and unannounced audits at APSL and SBP to ensure online compliance
- Review presentations and Presenting quality issues for management review meetings, quality review meetings etc
- Providing Training on cGMP, GDP, GLP and SOPs and quality guidelines and providing training to other DQA members on regulatory guidelines and updates
- To review and approval of calibration and preventive maintenance schedule and to ensure the activity carried out as per the schedule
- Monitoring and ensuring the electronic data are backed-up using appropriate media (CDs I DVDs I Tapes) as per the periodicity defined in respective SOP in A R&D Lab
- Handling of all QA activities in absence of Head Quality Assurance
- Any other responsibilities assigned by the Head Quality Assurance.
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