Officer, QA Doc Cell

AHMEDABAD (IN)ONSITEPOSTED: 9/26/2026
PHARMAFull-time
HIRING ORGANIZATIONAMNEAL PHARMACEUTICALSPharmaceuticals / Healthcare
Amneal Pharmaceuticals

ROLE OVERVIEW

Supports the QA documentation cell within a pharmaceutical manufacturing environment by maintaining quality documentation systems, monitoring compliance, supporting audits and inspections, and assisting with quality issue resolution.

ROLE DEFINITION & RESPONSIBILITIES

  • •Assist in defining quality documentation activities, processes and standards under cGMP requirements
  • •Maintain QA documentation infrastructure and systems
  • •Participate in audits and monitoring of documentation processes and manufacturing outputs
  • •Maintain workflows, procedures, policies and inspection programs
  • •Support in-process quality monitoring and vendor quality interactions
  • •Report and troubleshoot manufacturing process deviations and documentation defects
  • •Compile APQR reports and maintain documentation under 21 CFR Part 210 and 211
  • •Support change control and deviation management
  • •Participate in complaint and recall assessments and CAPA implementation
Reporting Hierarchy: Works within the Quality Assurance documentation cell and supports senior quality personnel and relevant manufacturing and quality stakeholders; exact reporting line is not stated

* Role responsibilities and qualifications synthesized based on industry benchmark standards.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Pharmaceutical quality assurance or documentation knowledge
  • Understanding of cGMP requirements and pharmaceutical manufacturing documentation
  • Familiarity with quality systems and regulatory compliance
  • Ability to support audits, deviations and documentation review

PREFERRED QUALIFICATIONS

  • •Knowledge of APQR, 21 CFR Part 210 and 211, change control, deviation management, complaint and recall processes, CAPA and vendor quality management

REQUIRED VERIFIED SKILLS

QA documentation
cGMP
pharmaceutical manufacturing
quality systems
auditing
monitoring
documentation control
APQR
21 CFR Part 210 and 211
deviation management
change control
CAPA
complaints
recalls
troubleshooting

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Quality assurance documentation role within pharmaceutical manufacturing; structured exposure to cGMP documentation, regulatory compliance, auditing, deviation management, change control, complaints and recalls
No salary, bonus or equity amount is provided in the supplied job description; compensation should be confirmed during recruitment.

ORGANIZATION CONTEXT & CULTURE

Amneal Pharmaceuticals is a pharmaceutical company involved in developing, manufacturing and supplying pharmaceutical products across multiple markets.

TEAM SIZE: 10,000+ employees
INDUSTRY: Pharmaceuticals / Healthcare
Culture: Quality-focused environment emphasizing regulatory compliance, documentation accuracy, structured quality systems and collaboration with manufacturing and quality stakeholders.

EXPECTED CAREER ROADMAP

Potential progression may include Senior Officer or Executive QA roles, QA documentation leadership, Quality Systems, Compliance or broader pharmaceutical Quality Assurance positions.

APPLICATION ADVISORY

Highlight pharmaceutical QA or documentation experience, cGMP knowledge, familiarity with 21 CFR requirements, deviation/change control exposure, APQR and CAPA knowledge, documentation accuracy and audit support skills.
RECOMMENDED TRAINING
1/5

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