About the role

Aplyr's Quick Take

This role is primarily about overseeing quality assurance processes in a laboratory setting, focusing on compliance with quality management systems and regulatory requirements. It’s an individual contributor position that requires significant experience in quality assurance, particularly in handling investigations and documentation related to lab results.

Good fit

Ideal candidates are those with 12-14 years of experience in quality assurance, preferably with a background in pharmaceuticals and familiarity with Abbott's standards. A hands-on, detail-oriented working style is essential.

Worth noting

The position emphasizes a strong understanding of QMS and laboratory compliance, which may be a red flag for those not already experienced in these areas. Additionally, the preference for candidates with prior Abbott experience suggests a potential bias towards internal hires.

JOB DESCRIPTION:

Position : Assistant manager
Section : Analytical Quality Assurance

Qualification : M.Sc. /B. Pharm.

Desirable Experience: 12-14 years

Followings will be the responsibilities of the position holder:

1. Quality Management System (QMS): Must be well-versed in handling QMS systems, including documentation, audits, CAPA, and compliance activities.

2. OOS/OOT & Investigations:

Proven experience in managing Out of Specification (OOS) and Out of Trend (OOT) incidents.

Should have handled both Phase-I and Phase-II investigations independently, with thorough documentation and root cause analysis.

3. Preferably has worked with Abbott for a minimum of 3 years, demonstrating familiarity with their quality standards and operational procedures.

4. To ensure effective implementation of system and procedure as per cGMP, cGLP and other Regulatory requirements, and monitor its compliance.

5. To participate in investigation exceptions, market complaints and review the investigation report.

6. Practical understanding of HPLC (Empower software) , GC and laboratory instrument handling.

7. To act as a laboratory compliance administrator for creation of new users and projects and to review the audit trials.

8. Handling of QMS activities (Change Control, Deviations, Exceptions, CAPA, Market complaints, Effectiveness Checks) To ensure the effective implementation of QMS through TrackWise system.

9. Ensure Compliance of QMS related SOPs /records.

10. To strategize and plan continual improvement in all laboratory activities as per GMP and GLP requirements.

11. Review, approval of qualification and Validation documents (URS, DQ, IQ, OQ, PQ etc.)

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

EPD Established Pharma

LOCATION:

India > Village Mauza : Baddi

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Aplyr's read

Abbott Laboratories is a leader in healthcare innovation, attracting professionals dedicated to advancing medical technology and patient care on a global scale.
Synthesized from recent postings & public sources

What's promising

•Abbott's diverse product range offers stability and growth opportunities.
•Strong global presence enhances career mobility and international experience.
•Commitment to R&D fosters a culture of innovation and learning.

What to watch

•Regulatory challenges can impact product launch timelines.
•High competition in the healthcare sector pressures market share.
•Complex organizational structure may slow decision-making processes.

Why Abbott

•Abbott's focus on both diagnostics and nutrition sets it apart from typical pharmaceutical companies.
•Extensive global footprint provides unique cross-border project opportunities.
•Abbott's investment in emerging markets offers growth in diverse regions.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Abbott

Abbott

abbott.com

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Abbott Laboratories is a global healthcare company that develops and manufactures a wide range of medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals.