Lead Associate - Quality Assurance (Manufacturing)

10-12 years

$80,000 - $90,000 per annum

Middleburgh

12 Nov. 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Lead Associate, Quality Assurance - Middleburgh Plant (On Site)

Company: Dr. Reddy’s Laboratories Ltd.

Location: Middleburgh, NY, USA

About Dr. Reddy’s Laboratories: Dr. Reddy's is committed to providing affordable and innovative medicines worldwide. With a focus on "Good Health Can’t Wait," we strive to help people lead longer, healthier lives. We are an inclusive employer, welcoming diverse talent, and fostering a culture of empathy, collaboration, and shared success.

Job Summary: We are looking for a Lead Associate Quality Assurance to support Quality Assurance activities at our Middleburgh plant. This role will collaborate closely with the Site Quality Head to ensure all operations are conducted following cGMP (current Good Manufacturing Practices) and regulatory guidelines, with a focus on continuous improvement and compliance.

Key Responsibilities:

Manage the Quality System with a focus on continuous improvement and compliance with cGMP, FDA regulations, and internal SOPs.
Oversee Reserve sample programs, ensuring adherence to internal procedures.
Manage documentation for Annual Product Reviews, SOPs, Change Controls, Complaints, Investigations, CAPAs, Stability Management, IQ/OQ/PQ protocols, and validation reports.
Ensure quality stream documents (e.g., deviations, investigations) are completed accurately and on time.
Oversee artwork and specification changes related to labeling.
Assess compliance aspects of computer systems (e.g., Empower).
Stay updated on compliance requirements, regulatory developments, and industry trends.
Handle product assurance functions, including batch record review and finished goods release.
Approve deviations and non-conformance reports.
Manage training and education programs for cGMPs and company policies.
Control documentation, including SOPs, master batch records, and historical files.
Conduct and manage GMP audits, ensuring corrective and preventive actions (CAPAs) are implemented.
Maintain product surveillance and risk management systems, addressing any identified compliance risks.
Assist with managing the Approved Vendor List for inventory suppliers.

Qualifications:

Educational Qualification: BS in Chemistry, Pharmacy, Biological Sciences, or related field.
Work Experience: Minimum of 10-12 years of experience in Pharmaceutical/QA roles.
Skills & Knowledge:
- Strong knowledge of FDA regulations, cGMP, and labeling requirements.
- Understanding of CFR and pharmacopoeial requirements.
- Experience with audit processes and regulatory agencies (FDA).
- Strong validation knowledge.
- Management and analytical thinking skills.
- Experience with USP and other compendial requirements.
Additional Requirement: U.S. citizen, lawful permanent resident, or authorized to work in the U.S. without sponsorship.

Salary Range: $80,000 - $90,000 per annum

Our Work Culture: At Dr. Reddy’s, we believe in the power of people, teamwork, and shared success. We’re dedicated to creating an empathetic and dynamic workplace, focused on improving healthcare and empowering communities to stay fit and healthy. We believe that when diverse skills unite under a common purpose, we can achieve extraordinary results.

Equal Opportunity Employer: We are an equal opportunity employer and welcome applicants regardless of race, religion, gender, age, or any other protected characteristic.

For more details and to apply, visit our career website.

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