Associate Manager-Quality Investigation
1 week ago
Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients.
What You Will Achieve
In this role, you will:
- Investigate quality issues within manufacturing and quality laboratories
- Examine deviations, out-of-specification results, and atypical investigations
- Identify root causes and suggest effective corrective action plans
- Ensure all reports comply with regulatory requirements and company policies
- Contribute to moderately complex projects, managing your own time to meet targets
- Develop plans for short-term work activities within a collaborative team environment
- Apply skills and discipline knowledge to contribute to work within the Work Team
- Make decisions to resolve moderately complex problems in standard situations
- Work under general supervision, following established procedures and general instructions
- Periodically review work, and may review the work of other colleagues in a mentor role
Here Is What You Need (Minimum Requirements)
- Preferably 6- 8 years' experience in Quality Assurance function of sterile manufacturing facility.
- Proven record of problem-solving and decision-making skills
- Experience in the pharmaceutical sterile industry
- Strong background and knowledge in manufacturing, compliance, and technology investigations, processes, and systems
- Ability to work both independently and collaboratively
- Effective communication skills, both written and verbal
- Computer literate with superior skills in managing Excel spreadsheets
Bonus Points If You Have (Preferred Requirements)
- B.Pharm/M.Pharm/M.S(Pharmacy)/ M.Sc.(Chemistry/Microbiology)
- Experience with investigations, including conducting and writing investigations using methodology
- Familiarity with regulatory requirements and quality standards
- Strong analytical and critical thinking skills
- Ability to manage multiple projects simultaneously
- Experience with root cause analysis and corrective action plans
- Excellent organizational skills
- Ability to mentor and guide junior colleagues
- Strong interpersonal skills and the ability to foster a collaborative team environment
Work Location Assignment: On Premise
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