Analytical Testing & Documentation Expert R&D (Pharma Aurangabad)

Position: Analytical Testing & Documentation Expert R&D
Department: R&D Analytical
Experience: 7-12 Years

Location, Aurangabad
Industry: Pharmaceutical Formulation / Finished Dosage Forms
Qualification: M.Pharm / M.Sc. (Analytical Chemistry / Pharmaceutical Chemistry)

Key Responsibilities We are looking for an experienced Analytical Testing & Documentation Expert for our R&D Analytical Department who can independently handle analytical testing as well as regulatory and technical documentation related to product development, stability studies, analytical method validation and dossier submission.

The candidate should have strong hands-on knowledge of analytical testing and excellent expertise in preparation, review and compilation of analytical documents in accordance with current ICH, pharmacopoeial and regulatory guidelines.

1. Analytical Testing

• Independently perform and/or supervise analytical testing of raw materials, finished products, stability samples and R&D/development batches.
• Hands-on experience with HPLC, UV-Visible Spectrophotometer, Dissolution Tester, GC and other routine analytical instruments.
• Testing of products for:
• Assay
• Related substances / impurities
• Dissolution / drug release
• Content uniformity
• Identification
• Preservative content, where applicable
• Other dosage-form-specific tests.
• Review chromatograms, calculations, analytical worksheets and raw data.
• Troubleshoot analytical methods and instrument/method-related problems.
• Knowledge of pharmacopoeial methods and specifications as per IP, BP, USP and Ph. Eur.

2. Stability Studies

Candidate must have strong knowledge and independent handling capability for:

• Preparation of Stability Study Protocols.
• Preparation and maintenance of stability study schedules.
• Understanding of long-term, accelerated and intermediate stability conditions.
• Stability sample planning, charging, withdrawal and testing coordination.
• Review and trending of stability data.
• Evaluation of assay, impurities/degradation products, dissolution and other stability-indicating parameters.
• Preparation of Stability Study Reports / Summary Reports.
• Preparation of stability data for regulatory dossier submissions.
• Identification and investigation of abnormal trends, OOS/OOT results and significant changes.
• Knowledge of ICH Q1 series stability guidelines.

3. Analytical Method Validation AMV

Candidate should be capable of independently preparing and reviewing:

• Analytical Method Validation Protocols
• Analytical Method Validation Reports
• Analytical validation worksheets and calculations.

4. Stability-Indicating Methods / Forced Degradation

• Knowledge of development and validation of stability-indicating analytical methods.
• Understanding of forced degradation studies under appropriate stress conditions such as acid, alkali, oxidation, thermal, photolytic and humidity stress, as applicable.
• Evaluation of degradation products and interference.
• Understanding of peak purity and mass-balance concepts.
• Preparation of forced degradation study protocols, data summaries and reports.

5. Regulatory Dossier – Analytical Documentation

Candidate must be capable of independently preparing, reviewing and compiling analytical sections of regulatory dossiers.

Expected working knowledge of CTD/ACTD analytical documentation, particularly:

6. Specifications, STPs & Analytical Documentation

7. Regulatory Query Handling

The candidate must have demonstrated experience in:

• Analytical testing of pharmaceutical finished products.
• HPLC and dissolution testing.
• Analytical Method Validation.
• AMV protocol and report preparation.
• Stability protocol and stability report preparation.
• Stability data evaluation and trending.
• Specification and STP preparation.
• Analytical method transfer/verification.
• Analytical dossier documentation.
• CTD/ACTD analytical sections.
• Handling analytical regulatory queries.
• Working with IP/BP/USP/Ph. Eur. requirements.
• Good technical writing and documentation skills.

Preferred Experience

Preference will be given to candidates having exposure to multiple dosage forms such as:

Tablets | Capsules | Oral Liquids | Dry Syrups/Suspensions | Injectables | Ophthalmic Products | Topical/Semisolid Products

Exposure to semi-regulated export markets and preparation of dossiers for multiple countries will be an added advantage.

Most Important Selection Criteria

This position requires a combination of hands-on analytical knowledge and strong regulatory documentation expertise.

The preferred candidate should be capable of independently handling the complete analytical documentation cycle:

Analytical Testing Method Development/Verification AMV Protocol Validation Execution/Data Review AMV Report Stability Protocol Stability Data Review Stability Report Specification/STP CTD/ACTD Analytical Documentation Regulatory Query Response.

How to Apply

Interested candidates can share their updated resume at [email removed]

or whatsapp your CV on [phone removed]