Philippines Test JR

Dr Reddy's Laboratories Ltd - Sandbox; Manila; On-site; PHP 800,000 - 1,200,000; Full time

Job summary

A leading pharmaceutical company in Manila seeks a Quality Assurance professional with over 8 years of experience in the pharmaceutical sector. The role involves providing Quality support for analytical and operations issues, ensuring compliance with industry standards, and representing the company during regulatory inspections. Ideal candidates should hold a relevant Bachelor’s degree and possess strong knowledge in pharmaceutical manufacturing and quality control processes, along with excellent communication skills.

Qualifications

• 8+ years of experience in pharmaceutical and/or biotech sectors.
• Experience in handling Analytical Method Validation and investigations.
• Thorough understanding of GMP regulations.

Responsibilities

• Provide Quality support related to Analytical and Operations issues.
• Ensure Data Integrity and data review controls across North America.
• Represent during FDA/other regulatory inspections.

Skills

Pharmaceutical manufacturing knowledge

Laboratory techniques (HPLC, GC)

Quality assurance

Excellent communication skills

Analytical and investigative skills

Education

Bachelor’s Degree in Life Sciences or related field

Job description

• Sub Job Family: Customer Service General(115)
• Job Family: Customer Service_old1

Company Description

At Dr. Reddy's "Good Health Can't Wait"
By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.

Job Description

Responsibilities:

• Provides Quality support related to Analytical and Operations issues, Laboratory and Operations investigations, Product Specifications, Analytical Method Validation, Process Validation, Method and process Transfer and major Change Controls for commercial and products under development are reviewed by QA in a timely manner.
• Reviews, supports, escalates, and approves critical laboratory and manufacturing investigations.
• Ensures Data Integrity and data review controls and improvement efforts across the North America region.
• Support internal and external laboratory and CMO audits.
• Reviews/Approves Annual Quality Product Reports authored by Contract Manufacturers.
• Investigate and/or evaluate manufacturing and laboratory deviations or incidents and associated CAPAs. Provide direction and recommendations as to future course(s) of action.
• Review and approve Quality Agreements.
• Write, review, and implement SOPs to ensure compliance with current Dr Reddy’s standard and cGMP. Supports product recalls and executes plan as assigned.
• Represent Dr Reddy’s during FDA/other regulatory inspections and corporate GMP compliance audits as defined in related Quality Agreements.
• Assist with preparation of audit observations.
• Support the Product Compliant program, investigations, and trending metrics.
• Serve as a backup to multiple critical roles within the QMS teams.

Qualifications

Qualifications / Skills:

• Bachelor’s Degree (or its U.S. equivalent) in Life Sciences, Pharmaceutical Sciences, or a closely related field with 8+ years of experience in a pharmaceutical and/or biotech.
• Strong knowledge in In Pharmaceutical manufacturing and/or Laboratory techniques; especially Chromatography (HPLC, GC), Dissolution and compendia test procedures, combination products, Quality assurance and Quality Control.
• Experience in the manufacture of drug substances and/or drug product or quality control laboratories is desired.
• Experience in handling Analytical Method Validation, Method Transfer activities experience in handling Laboratory and Manufacturing investigations, Deviations, Out of Specifications/Out of Trends, SCARS and CAPAs.
• Strong understanding of pharmaceutical processes and/or method development and testing processes, and familiarity with Quality Management Systems.
• Familiarity with Data Integrity and Data review controls.
• Thorough understanding of GMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA guidance documents.
• Must have prior experience in working with cross-functional teams.
• Excellent communication (verbal and written), strong analytical and investigative, critical thinking, organizational and time management skills; Strong attention to detail.
• Excellent negotiation and influencing skills required.
• Capable of managing multiple priorities.
• Able to rapidly adapt to changing environment and a circumstance requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met.
• Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems.

Additional Information

Diversity, Equity & Inclusion
At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.

Purpose:
The Associate will provide support to the Middleburgh site in all Quality Assurance activities. Closely work with site Quality head to maintain that all aspects of the site operations are conducted using cGMP methodology as well as following all current regulatory guidelines.