PHARMA STUFF

Quality Assurance Associate

Written by

Sudheer vanguri

in

Dr Reddy’s Laboratories is recruiting a Quality Assurance Associate for the Biologics department in Bachupally, Telangana.

This role is open to candidates with a BPharm or a postgraduate degree in Life Sciences and at least 5 years of industrial experience in Manufacturing, QA, or Development.

Job Details

Particulars Details
Company Dr. Reddy’s Laboratories
Position Quality Assurance Associate
Department Biologics
Location Bachupally, Telangana, India
Qualification BPharm or Post-Graduation in Life Sciences
Experience Minimum 5 years
Employment Type Full-time
Work Mode On-site

Job Responsibilities

Supplier Qualification and Lifecycle Management

  • Qualify and manage the lifecycle of service providers and consumable vendors.

  • Handle material complaints.

  • Carry out periodic vendor and service provider qualification audits.

  • Establish and periodically refresh quality agreements.

  • Secure prompt and compliant qualification of all vendors and materials used in commercial manufacture.

  • Periodically check GMP records in accordance with the ALCOA principle.

External Manufacturing Quality Assurance

  • Carry out quality due diligence and qualification of any prospective insourcing or outsourcing partners.

  • Establish, review, negotiate and maintain Quality Agreements with external manufacturing, testing and service partners.

  • Monitor compliance with Quality Agreement commitments via the scheduled reviews and governance activities.

  • Receive, assess, approve and track change notifications from external partners (including quality, regulatory and supply impact assessments).

  • Review and monitor deviations, investigations, CAPAs, complaints and OOS/OOTS relating to external operations.

  • Perform quality risk assessments and provide GMP oversight for all outsourced manufacturing and testing.

  • Participate in audits, partner performance reviews and inspection readiness activities.

  • Monitor external partners’ quality through measurements, scheduled reviews, and escalation of critical quality issues.

  • Work with cross-functional teams to manage the quality systems and compliance requirements associated with external manufacturing.

Eligibility Criteria

Educational Qualification

  • BPharm

  • Postgraduate degree in Life Sciences

Work Experience

  • Minimum 5 years’ relevant industrial experience.

  • Experience in Manufacturing, Quality Assurance or Development is required.

Technical Skills

  • Good knowledge of Quality Systems and ability to work within cross-functional teams.

  • Knowledge of the biopharma and pharma markets, products and customer requirements.

  • Understanding of global cGMP regulatory requirements (i.e., FDA, EU, and Indian).

  • Awareness of pharma market trends.

  • Knowledge of the products (pharmaceuticals), the processes (manufacturing) and the standards (quality).

  • Ability to implement the organisation’s policies and ensure compliance.

Behavioural Skills

  • Willingness to learn and to update skills.

  • Strong communication and interpersonal skills.

  • Analytical and logical thinking skills.

  • Self-motivation and initiative.

  • Adaptability and ability to work in a team.

  • Proactive approach to work.

About the Biologics Department

The Biologics team at Dr Reddy’s focuses on biosimilars and covers key therapeutic areas.

The department has in-house expertise in clone development, upstream and downstream process development, bioanalytical development and formulation. Clinical and regulatory teams support biosimilar development and global clinical programmes.

Dr Reddy’s has commercial-scale manufacturing facilities across a number of technology platforms and has the experience of launching biosimilars in a number of markets.

Benefits

Dr Reddy’s offers the following benefits to employees:

  • Joining and relocation support.

  • Maternity and paternity benefits.

  • Learning and development opportunities.

  • Medical cover for staff and their families.

  • Life coverage.

Application Process

Interested and eligible applicants should apply online via the official LinkedIn job advert.

Apply Online: https://www.linkedin.com/jobs/view/4487425834/

Candidates should follow the company’s formal recruitment process. Dr Reddy’s advises candidates to be very wary of fake job offers and unauthorised recruitment agencies.

Job Summary

Company Department Position Qualification Experience Location
Dr. Reddy’s Laboratories Biologics Quality Assurance Associate BPharm / Post-Graduation in Life Sciences Minimum 5 years Bachupally, Telangana

More posts