Enaltec Pharma Research Pvt. Ltd. has announced an opportunity for experienced pharmaceutical professionals for the position of Officer / Sr. Officer – Quality Assurance (Formulation DQA) at its Ambernath MIDC facility in Thane, Maharashtra.
This Enaltec Pharma QA job is suitable for candidates with 2–4 years of hands-on experience in Formulation Development Quality Assurance (DQA) who can independently review pharmaceutical development, validation, stability, technology transfer and quality-system documentation.
Professionals searching for Quality Assurance jobs in Thane, Formulation DQA jobs in Mumbai/Thane, pharmaceutical QA jobs in Ambernath, or Officer/Sr. Officer QA vacancies can review the eligibility and responsibilities below.
Enaltec Pharma Job Details
| Particular | Details |
|---|---|
| Company | Enaltec Pharma Research Pvt. Ltd. |
| Position | Officer / Sr. Officer – QA |
| Department | Quality Assurance |
| Function | Formulation Development QA / DQA |
| Experience | 2–4 Years |
| Location | Ambernath MIDC, Thane, Maharashtra |
| Industry | Pharmaceutical / Formulation R&D |
| Employment Type | Full-Time |
| Application Mode |
Key Responsibilities – Formulation DQA
The selected candidate will support Formulation Development Quality Assurance activities and should be capable of independently handling and reviewing critical pharmaceutical quality documentation.
Key responsibilities include:
- Prepare and review Quality Assurance SOPs and associated controlled documentation.
- Review Product Development Reports (PDRs) for pharmaceutical formulations.
- Review Drug Master File (DMF) documentation.
- Review Analytical Method Validation protocols and reports.
- Review Standard Testing Procedures (STPs) and Certificates of Analysis (COAs).
- Review Working Standard qualification data and associated Certificates of Analysis.
- Prepare and review In-process, Release and Shelf-Life Specifications.
- Review Stability Protocols and Prototype Batch Stability Data/Results.
- Review equipment Calibration Reports and Cleaning Verification documentation.
- Review Bill of Materials (BOM) and Master Formula Cards (MFC).
- Review Trial and Exhibit Batch Manufacturing Records and BPRs.
- Review Process Evaluation and Hold-Time Studies.
- Review Sampling Protocols and Process Validation Protocols.
- Handle and review Technology Transfer documentation.
- Manage and review Change Controls, Deviations, Incidents and CAPA.
- Handle and review OOS (Out of Specification) and OOT (Out of Trend) investigations.
- Support Vendor Qualification and Vendor Audits.
- Participate in Internal Audits and Self-Inspections.
- Coordinate with cross-functional departments on quality and regulatory compliance requirements.
- Support CMO documentation and dossier filing activities.
- Review Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports.
Desired Candidate Profile
Enaltec Pharma is looking for a technically strong and detail-oriented professional with relevant experience in Formulation Development QA / DQA.
Candidates should ideally have:
- 2–4 years of relevant pharmaceutical QA experience.
- Hands-on experience in Formulation DQA / Development Quality Assurance.
- Strong knowledge of pharmaceutical quality documentation.
- Experience reviewing development, analytical, manufacturing and validation documentation.
- Understanding of Change Control, Deviation, CAPA, OOS and OOT systems.
- Knowledge of Process Validation and equipment qualification documentation.
- Experience with Technology Transfer documentation.
- Familiarity with pharmaceutical regulatory and quality requirements.
- Experience coordinating with Quality, Regulatory, R&D, manufacturing, CMO and other cross-functional teams.
- Ability to independently manage and review assigned DQA activities.
- Strong attention to detail and documentation skills.
Note on qualification: The recruitment information provided does not specify a particular educational qualification. Candidates should verify qualification requirements directly with the employer before applying.
Skills Relevant to This QA Vacancy
Candidates with experience in the following areas may be particularly relevant for this Formulation DQA job in Thane:
Formulation DQA | Quality Assurance | SOP Review | PDR | DMF | STP | COA | Stability Studies | Process Validation | Technology Transfer | CAPA | Change Control | Deviation | OOS | OOT | Vendor Qualification | Internal Audit | DQ | IQ | OQ | PQ | Regulatory Compliance
Why Consider This Opportunity?
This role provides experienced QA professionals with exposure to a broad range of Formulation Development Quality Assurance activities, including development documentation, validation, stability, technology transfer, investigations, audits and regulatory support.
The position may be particularly relevant for professionals looking to strengthen their experience across pharmaceutical development quality systems while working closely with cross-functional technical and regulatory teams.
Specific salary, incentives, insurance, leave, transportation and other employee benefits were not disclosed in the recruitment information and should be confirmed directly with Enaltec Pharma during the selection process.
How to Apply for Enaltec Pharma QA Jobs
Interested and eligible candidates can send their updated resume/CV directly to the email address provided by Enaltec Pharma.
Email: naresh.raikot@enaltec.com