Talent.com
Dr Reddy's Laboratories Limited
Qualified Person UKDr Reddy's Laboratories Limited • Cambridge, England, UK
Qualified Person UK

Qualified Person UK

Dr Reddy's Laboratories Limited • Cambridge, England, UK
8 days ago
Job type
  • Full-time
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 be responsible for certification and release of medicinal product batches. You will support Quality Management Systems and compliance activities.


Qualifications :

Responsibilities:

  • To support Quality Assurance in efficient functioning and implementation of all Quality plans at site
  • Ensuring that all activities are performed in accordance with the regulatory and legal requirements and in compliance to the requirements of the current GMP GDP company SOPs and Health and safety policies / SOPs
  • Creation implementation monitoring review and continuous improvement initiatives of cGMPs Quality Management Systems (QMS) and procedures as assigned / required by Head of Quality
  • Conducting External Audit system liaising with clients and auditors ensuring audits are planned and performed within given timelines
  • Reviewing audit reports for completion including audit close out following up on audit response plan ensuring all actions are completed and within given timelines
  • Providing QP support in the evaluation of investigation and documentation pertaining to quality of products or processes e.g change controls deviations quality incidents OOSs OOTs CAPAs complaints recalls pertaining to quality of product or process as applicable
  • Review and decision making on the fate of change controls deviations complaints CAPAs related to vendors and service providers
  • Review and approval of periodic product quality review and identify any risk associated with product / facility during the review period
  • Undertaking the duties of a Qualified Person in accordance with EU directives 2001/83/EC and 2001/82/EC products where permitted by the Cambridge site MIA
  • Motivating coaching and mentoring Quality team members and providing direction 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 and Quality systems in place at Dr. Reddys Cambridge is efficient effective and enable the organization to achieve its Quality Regulatory and Business objectives
  • Working as a Responsible Person (import) (RPi) as described in regulations 45AA and 45AB of the Human Medicines Regulations 2012 (as amended)
  • Assist with the activities required to carry out the closure of the Beverely site and transfer of the QMS activity to the Cambridge site
  • Assist with the activities required to add Biologics as a permitted product category to the Cambridge 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 and understood


Additional Information :

Education & Experience:

  • Master Degree 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

Key Skills & Competencies:

  • GMP/GDP expertise

  • Strong auditing and compliance knowledge

  • Analytical decision making

  • Stakeholder management

  • Excellent communication skills


Remote Work :

No


Employment Type :

Full-time


Experience: years
Vacancy: 1
Create a job alert for this search

Qualified Person UK • Cambridge, England, UK

Similar jobs

Salaried GP

The Clarkson SurgerySouth Cambridgeshire, England, GB
Full-time +1

Are YOUwho we are looking for?.We have anexciting opportunity for an enthusiastic and caring part time (6 sessions) or full time (8-9 sessions) salaried GP to join our friendly and patient focused ... Show more

 • Promoted

Yard Operative/Plant Machinery

Meridian Business Support LimitedAston, Wales, United Kingdom
Temporary

Meridian business support is recruiting for aYard operative / FLT Driver/Plant for a Company based in Deeside.Yardoperative /FLT Driverand Plant Machinery Must have a valid FLT licence and some ot... Show more

 • Promoted

Shop Manager - Royston

Wood GreenRoyston, England, GB
Full-time +1

Would you like to support Woodgreen in achieving its goal of helping people and their pets?.Do you enjoy working in a busy fast paced environment to maximise sales through high standards of custome... Show more

 • Promoted

Quality Assessor

Staffline OperationsWyton, Cambridgeshire, GB
Full-time

Great opportunity to work as a.This is an excellent opportunity for someone with a keen eye for detail and a passion for maintaining high quality standards within a fast-paced production environmen... Show more

 • Promoted

Newly Qualified Dentist

mydentistCambridgeshire and Peterborough, England, GB
Full-time +1

Your future, as a Self-employed Newly Qualified Dentist at mydentist.You’ll be joining us at our Peterborough practice at Church Street.There is space available for full time or part time, and we w... Show more

 • Promoted

Apprentice Chef - £26,334 A Year - No Experience Required

The ArmyCambridge, United Kingdom Of Great Britain And Northern Ireland, UK
Full-time

As a full-time soldier, entry-level Chef in the British Army, youll:.Provide everything from fine dining and state banquets to humanitarian aid and disaster relief.Be part of a highly respected, sp... Show more

 • Promoted

Teaching Assistant

Positive Futures Recruitment LtdRoyston, ENG, GB
Full-time

Job Title: Teaching Assistant - Specialist SchoolLocation: Meldreth, Cambridgeshire/ HertfordshireSalary: £22,996 to £25,068 (Actual annual salary, dependent on experience and qualifica... Show more

 • Promoted

General Operative

Job&talentSpalding, Lincolnshire, GB
Full-time

Please ensure you read the below overview and requirements for this employment opportunity completely.We are recruiting for General Operatives for one of our clients based in Spalding.Market leadin... Show more

 • Promoted

General Operative

Moulton Bulb Co. LimitedHolbeach, ENG, GB
Full-time

This role covers various functions in order to fulfil orders as per customer specifications and standardsWorking hours: 07:00am - 6:30pm on a 4 on, 4 off shift patternThe PositionTrim, peel, bag an... Show more

 • Promoted

Graduate NPD Technologist

Freeworld FoodsSpalding, ENG, GB
Full-time +1

Salary £30,000 to £35,000 per annum dependant on experienceWorking hours full time, permanentLocation Office based/Spalding centre, LincolnshireBenefits Great team culture and ethos, co... Show more

 • Promoted

Qualified Nursery Practitioner

Family First Nursery GroupCoton, England, United Kingdom
Full-time +1

Level 3 Nursery Practitioner / Early Years Practitioner .Full-time Hours, Monday - Friday with flexible options available.Coton C of E Community Primary School, Whitwell Way, Coton, Cambridge, UK.A... Show more

 • Promoted

Team Leader

ctrgEngland, Cambridgeshire, Wisbech
£14.60 hourly
Full-time
Quick Apply

Are you an effective communicator, a great strong leader? If so, ctrg is currently offering a great opportunity for you to join the production team as a full time Team Leader in.Your pay rate as a ... Show more

Sexual Offence Examiner/Forensic Physician/Doctor - EAST

Mountain Healthcare LimitedCambridge, ENG, GB
Full-time

Ready for a career that's truly different?.Mountain Healthcare is one of the UK's leading providers of forensic healthcare within the Health and Justice sector.Working in partnership with N... Show more

 • Promoted

Consultant in Adult Psychiatry – Peterborough

Pulsejobs.comCambridgeshire and Peterborough, England, GB
Full-time

Consultant in Adult Psychiatry.Competitive, to be discussed upon application.We are looking for a dedicated Consultant in Adult Psychiatry to join our client’s team in Peterborough, Cambridgeshire.... Show more

 • Promoted

Self-Employed PAT Testing Engineer | Flexible Hours

JrpattestingGuilden Morden, England, GB
Full-time +1

Jrpattesting is expanding in the UK, currently seeking experienced self-employed PAT Engineers in Guilden Morden.This role offers flexible hours, making it suitable for part-time or full-time work.... Show more

 • Promoted

Recruitment Consultant

Nexus PeopleHardwick, England, GB
Full-time

On-site Recruitment Consultant.Sunday to Wednesday (12:00 - 22:00) – full-time, with potential additional hours during busy periods.Previous experience working in Logistics recruitment – essential.... Show more

 • Promoted

Hybrid Part-Time MASH Decision Maker, Child Protection

Service Care SolutionsCambridgeshire and Peterborough, England, GB
Part-time

A leading social care provider is seeking a skilled Decision Maker - MASH for a part-time position in Cambridgeshire and Peterborough.The role involves assessing referrals and ensuring effective co... Show more

 • Promoted

Qualified Social Worker - Duty And Assessment

Remedy Social WorkMoulton, England, GB
Full-time

Our client Northamptonshire's Children's trust is looking for a Qualified social worker to join their Duty and assessment team.The Duty and assessment team is the frontline, single point of contact... Show more