At Dr. Reddy's \"Good Health Can't Wait\"
By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference fortheircommunity andeverycommunity.
Diversity, Equity & Inclusion
At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.
Job Description
We are seeking a Qualified Person in our Quality Assurance team to be based in person from our Cambridge, UK office and report to Head, Quality - UK. You will beresponsible for certification and release of medicinal product batches. You willsupport Quality Management Systems andcompliance activities.
Qualifications
Responsibilities:
- To support Quality Assurance in efficient functioning and implementation of allQuality plans at site
- Ensuring that all activities are performed in accordance with the regulatory andlegal requirements and in compliance to the requirements of the current GMP,GDP, company SOP’s and Health and safety policies / SOP’s
- Creation, implementation, monitoring, review and continuous improvementinitiatives of cGMP’s, Quality Management Systems (QMS) and procedures asassigned / required by Head of Quality
- Conducting External Audit system, liaising with clients and auditors, ensuringaudits are planned and performed within given timelines
- Reviewing audit reports for completion including audit close out, following up onaudit response plan, ensuring all actions are completed and within giventimelines
- Providing QP support in the evaluation of investigation and documentationpertaining to quality of products or processes e.g change controls, deviations,quality incidents, OOSs, OOTs, CAPAs, complaints, recalls pertaining to qualityof product or process as applicable
- Review and decision making on the fate of change controls, deviations,complaints, CAPA’s related to vendors and service providers
- Review and approval of periodic product quality review and identify any riskassociated with product / facility during the review period
- Undertaking the duties of a Qualified Person in accordance with EU directives2001/83/EC and 2001/82/EC, products where permitted by the Cambridge siteMIA
- Motivating, coaching and mentoring Quality team members and providingdirection and guidance on quality and GMP issues
- Working with all members of staff and the senior management to develop,improve and maintain the positive quality culture within Dr. Reddys, Cambridge
- Member of the Quality team responsible for ensuring the cGMP compliance andQuality systems in place at Dr. Reddys, Cambridge is efficient, effective andenable the organization to achieve its Quality, Regulatory and Businessobjectives
- Working as a Responsible Person (import) (RPi) as described in regulations45AA and 45AB of the Human Medicines Regulations 2012 (as amended)
- Assist with the activities required to carry out the closure of the Beverely site, andtransfer of the QMS activity to the Cambridge site
- Assist with the activities required to add Biologics as a permitted productcategory to theCambridge site MIA
- Undertaking any other duties within Quality, which may be requested by the Head of Quality, for which training and / or an explanation has been provided andunderstood
Additional Information
Education & Experience:
MasterDegree in Pharmacy, Pharmaceutical Chemistry, Life Sciences or related field
Eligible to act as a Qualified Person under applicable UK/EU regulations
Significant Quality Assurance experience in pharmaceutical industry
GMP/GDP expertise
Strong auditing and compliance knowledge
Qualified Person - UK in Cambridge employer: Dr Reddy's Laboratories Limited
Dr. Reddy’s Laboratories Ltd. is an exceptional employer, offering a dynamic and entrepreneurial work culture that empowers employees to make a meaningful impact in the pharmaceutical industry. With a strong focus on employee growth and development, this role as a Commercial Manager provides opportunities for career acceleration and exposure to strategic decision-making within a globally recognised company. Located in the UK & Ireland, employees benefit from competitive compensation, a collaborative environment, and the chance to contribute to innovative healthcare solutions that truly matter.
Contact Details:
Dr Reddy's Laboratories Limited Recruitment Team
