Role details

Quality Assurance Manager

Mirfield   •  Permanent

Bullet points

  • Location: Mirfield
  • Reporting to: Quality Head CPS India & Mirfield

About Our Client

About Dr. Reddy's

Dr. Reddy's Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, with revenues of over USD 2.2 billion. We have commercial presence in more than 20 countries, and wholly-owned subsidiaries in the US, UK, Russia, Germany and Brazil and joint ventures in China, South Africa and Australia.

Dr. Reddy's has over 20,000 employees working across the globe in our 21 manufacturing facilities, four technology development centres, one integrated product development facility and two R&D centres.

We were ranked first among biotech and pharmaceutical companies in India by Great Place to Work in its Best Companies to Work For survey, 2013.

To know more about Dr. Reddy's please visit us at

Job Description

Roles and Responsibilities

  • Manage the formal planning and control of the day to day activities of the quality assurance department in order to meet product release dates
  • Identifying the resource requirements of the department, coordinating approvals and ensuring the required resources are available
  • Performance review and evaluation of team members to facilitate the competency development
  • Ensure QA personnel are appropriately trained prior to carrying out the job
  • Work with the regulatory function to provide input on product registration needs ie NDA information, DMF filing, supplements and annual review reports
  • Implementation of and adherence to business quality systems
  • Provide expertise and support on quality and cGMP compliance work processes to the plant partners
  • Provide batch release, incident investigation, planned deviations and management of change QA review
  • Maintain product, raw and packaging material specifications
  • Lead / participate in customer and agency audits and provide inputs to other departments in order to initiate changes based on audit responses
  • Work with customers to coordinate, document and communicate complaint and problem relation activities
  • Conduct internal audits
  • Review / approve validation protocols / reports
  • Review / approve SOPs, WIs, PRSs, SAMs and BMRs
  • Review / approve stability protocols / reports
  • Have authority to approve, reject and release intermediates and APIs
  • Ensuring that effective systems are used to approve or reject raw materials, packaging materials and labels
  • Review of completed BMRs and associated laboratory records before release of APIs for distribution
  • Conduct "out of trend" and "out of specification" investigation before release of product
  • Ensuring that specific stability data exists to support defined retest / expiry periods
  • Initiate microbiology studies
  • To actively participate in safety initiatives and ensure safety and other statutory compliance

The Successful Applicant

Academic Background and Experience required

  • Must be educated to graduate level in chemistry or a quality related subject
  • Must have a Quality Assurance background
  • Experience of manufacture of pharmaceutical APIs and fine chemical intermediates to appropriate standards of cGMP is essential
  • Working knowledge of FDA and MHRA regulatory requirements and ICH Q7 and ISO 9001 is essential
  • Experience of working cross functionally and with multidisciplinary teams is essential
  • Experience of managing a team would be advantageous

Key performance Indicators

  • Compliance with all cGMP and regulatory requirements
  • Completion of product release in a timely manner with minimum rejects, complaints and recalls
  • Timely closure of CAPAs
  • Comprehensive audit responses

Key skills and personal attributes

  • Excellent communication skills both written and verbal
  • Ability to contribute to effective team output by cooperation, participation and commitment to shared goals
  • Self-motivated with the ability to work independently and under pressure
  • Ability to build relationships with other functions and team working
  • Meticulous attention to detail
  • Ability to interpret and critically assess data
  • Ability to challenge and influence others
  • Problem solving skills
  • High standards of leadership and management skills

What's on Offer

A competitive base salary commensurate with skills and experience plus a generous benefits package.

Apply for this job

Click the Apply or LinkedIn button below or contact Lauren Allanson on +44 113 388 9047 quoting job reference 13708208
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