Lead Associate - Quality Assurance (Manufacturing)

10-12 years

$80,000 - $90,000 per annum

Middleburgh

10 Jan. 4, 2025

Job Description

Job Type: Full Time Education: BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description

At Dr. Reddy's Laboratories: "Good Health Can't Wait"

Joining Dr. Reddy’s means becoming part of a team that strives to make groundbreaking innovations in healthcare accessible today. From advancing affordability in medicine to exploring solutions for unmet medical needs, we are committed to improving lives worldwide. If you are dynamic, driven, and ready to inspire change, we invite you to join us in making a difference for communities everywhere.

Diversity, Equity, & Inclusion
At Dr. Reddy’s, diversity, equity, and inclusion are integral to our workplace culture. We value diverse perspectives and backgrounds, believing they drive innovation and success. We are committed to fostering an inclusive environment where everyone is recognized for their unique contributions and feels a sense of belonging.

Job Description: Lead Associate Quality Assurance

Location: Middleburgh Plant (On-Site)

Job Summary
The Lead Associate Quality Assurance will support and oversee Quality Assurance activities at the Middleburgh plant. The role involves ensuring site operations adhere to cGMP, FDA guidelines, and internal SOPs while collaborating closely with the Site Quality Head.

Responsibilities

Quality Systems Management:
- Oversee Quality System operations, emphasizing continuous improvement while ensuring compliance with cGMP, FDA standards, and internal SOPs.
- Manage reserve sample programs in alignment with internal procedures.
- Ensure completion and compliance of key documents such as Annual Product Reviews, Change Controls, Investigations, CAPAs, and validation protocols.
Documentation & Regulatory Compliance:
- Manage batch record review and release finished goods to stock.
- Draft, approve, and maintain deviations, non-conformance reports, and plant SOPs.
- Coordinate responses to regulatory agency queries regarding filings.
Training & Development:
- Develop and administer training programs on cGMPs and company policies.
- Maintain training records and implement in-house educational initiatives.
Auditing & Risk Management:
- Plan and conduct audits to identify and resolve deviations from GMP and QMS standards.
- Establish CAPA systems to ensure implementation of corrective actions.
- Capture, document, and mitigate compliance risks via risk management procedures.
Operational Management:
- Manage artwork and specification changes for labeling.
- Oversee Product Assurance activities and ensure timely completion of quality documents.
- Maintain the Approved Vendor List for suppliers.

Qualifications

Education:
- Bachelor’s degree in Chemistry, Pharmacy, Biological Sciences, or related fields.
Experience:
- 10–12 years of experience in the Pharmaceutical or Quality Assurance sector.
Technical Skills:
- Comprehensive knowledge of FDA regulations, cGMP, and labeling requirements.
- Proficiency in validation concepts, audit processes, and pharmacopoeial standards (e.g., USP).
- Strong understanding of CFR requirements and risk management processes.
Behavioral Skills:
- Effective management and communication skills.
- Strong analytical thinking and problem-solving abilities.
Work Authorization:
- Must be a U.S. citizen, lawful permanent resident, or authorized to work in the U.S. without sponsorship.

Additional Information

Pay Range: $80,000–$90,000 per annum.

Our Work Culture

At Dr. Reddy’s, our guiding principle is "Good Health Can’t Wait." Every employee plays a pivotal role in our mission to create innovative healthcare solutions that empower people to lead healthier lives. We foster a supportive and dynamic culture where teamwork, diversity, and individual growth are celebrated.

Equal Opportunity Employer
We are committed to equal employment opportunities and prohibit discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

For more details, visit: Dr. Reddy’s Careers

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Lead Associate - Quality Assurance (Manufacturing)

Job Description

Company Description

Job Description: Lead Associate Quality Assurance

Responsibilities

Qualifications

Additional Information

Our Work Culture

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